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Siemens Healthcare Diagnostics Recalls
692 recalls on record · July 4, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 25, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the qu
Hazard: Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Assays: Uric Acid (URCA)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Assays: Triglycerides (TRIG)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Assays: Enzymatic Creatine (ECRE)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Assays: Uric Acid (URCA)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Assays: Triglycerides (TGL)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Assays: ENZYMATIC CREATININE
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Assays: Direct HDL Cholesterol (AHDL)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Assay: Lactate
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemist
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA CHEMISTRY ENZYMATIC CREATININE_2
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Assay: LDL Cholesterol, Direct
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
Hazard: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well
Hazard: Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for th
Hazard: Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of metho
Hazard: Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.
May 18, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay
Hazard: The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
April 27, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-
Hazard: Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. As defined in t
March 30, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10
Hazard: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
March 30, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Prod
Hazard: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
March 30, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is a
Hazard: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
March 30, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage:
Hazard: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
March 16, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532
Hazard: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
March 16, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centa
Hazard: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
March 16, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Ce
Hazard: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
March 9, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889
Hazard: Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.