Siemens Healthcare Diagnostics Recalls

Hazard: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Hazard: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Hazard: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Hazard: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Hazard: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Hazard: Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample

Hazard: Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

Hazard: Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

Hazard: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Hazard: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Hazard: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Hazard: Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.

Hazard: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

Hazard: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

Hazard: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

Hazard: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

Hazard: Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.

Hazard: An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid

Hazard: Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

Hazard: Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

Hazard: Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

Hazard: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

Hazard: Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction

Hazard: Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction

Hazard: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

Hazard: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

Hazard: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Hazard: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Hazard: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Hazard: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results