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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.
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips
Hazard: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control
Hazard: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control St
Hazard: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360
Hazard: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistr
Hazard: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with
Hazard: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive a
Hazard: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
December 19, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 In
Hazard: Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
December 19, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US o
Hazard: Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
December 19, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended
Hazard: Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
December 19, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diag
Hazard: Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
December 19, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9
Hazard: Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
December 19, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081
Hazard: Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
December 19, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028
Hazard: Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
December 12, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quan
Hazard: Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON Flex(R) reagent cartridges have the potential for this issue. If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the mag
November 28, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro
Hazard: Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.
November 14, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantit
Hazard: Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
November 7, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tes
Hazard: BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
October 17, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n
Hazard: Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be obs
September 26, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS
Hazard: ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
September 26, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator
Hazard: ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
September 12, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays whe
Hazard: Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
September 12, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calcula
Hazard: When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte
September 5, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS A
Hazard: Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibration failures.
August 29, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in
Hazard: When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient
August 29, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA C
Hazard: Syphilis Assay Interference with HBsAg Assay
August 15, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical c
Hazard: Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected.
August 15, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of
Hazard: Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.
August 15, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing mo
Hazard: The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys
August 15, 2012Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calcula
Hazard: There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following