Siemens Healthcare Diagnostics

Complete recall history across all FDA and CPSC categories — 27 total recalls

Siemens Healthcare Diagnostics appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (27)

FDA medical device enforcement actions by Siemens Healthcare Diagnostics

Date Product Reason Class
Oct 17, 2017 BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 a... The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) ... Class II
Sep 19, 2014 IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 1... Customer complaints were received for positive bias reported on the controls ... Class II
Aug 19, 2014 ADVIA Centaur Immunoassay System (including refurbished units), This syst... The firm has identified an issue with patient demographic information sent to... Class II
Aug 19, 2014 ADVIA Centaur XP Immunoassay System (including refurbished units), This s... The firm has identified an issue with patient demographic information sent to... Class II
Aug 13, 2014 ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (S... The firm is conducting a field correction for the ADVIA Centaur and ADVIA Cen... Class II
Aug 13, 2014 ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers... The firm is conducting a field correction for the ADVIA Centaur and ADVIA Cen... Class II
Aug 6, 2014 ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems... The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to... Class II
Feb 18, 2014 ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyze... Instrument Cover Gas Spring failures. Over time, the gas spring may lose its... Class II
Dec 20, 2013 IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, S... Siemens Healthcare Diagnostics confirmed over-recovery of samples with concen... Class II
Dec 20, 2013 IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380... Siemens confirmed an overall average positive bias of 23% against the WHO 2nd... Class II
Dec 20, 2013 IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SM... Siemens Healthcare Diagnostics confirmed over-recovery of samples with concen... Class II
Dec 20, 2013 IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD -... Siemens confirmed an overall average positive bias of 23% against the WHO 2nd... Class II
Nov 6, 2013 IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ... potential for an accelerated decline in counts per second (CPS) for three IM... Class II
Sep 24, 2013 Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilir... Siemens Healthcare Diagnostics is conducting a field correction for Siemens C... Class II
Sep 3, 2013 ADVIA 2400 System Software V4.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due ... Class II
Sep 3, 2013 ADVIA 1800 System Software V2.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due ... Class II
Sep 3, 2013 ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due ... Class II
Sep 3, 2013 ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due ... Class II
Aug 27, 2013 T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material N... Siemens Healthcare Diagnostics confirmed customer complaints regarding an inc... Class II
Aug 27, 2013 T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 1... Siemens Healthcare Diagnostics confirmed customer complaints regarding an inc... Class II
Aug 12, 2013 ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN... Siemens determined that if an autosampler rack jam error occurs during operat... Class II
Jul 30, 2013 ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/US... Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a p... Class II
Jun 26, 2013 PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog N... Customers complained of a positive bias in patient results on the IMMULITE/ I... Class II
Jun 26, 2013 ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . ... The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 12... Class II
Nov 28, 2012 Immunoradiometric assay. Device is an immunoradiometric assay designed for... The recall was initiated because Siemens Healthcare Diagnostics confirmed an ... Class III
Nov 28, 2012 Immunoradiometric assay. The recall was initiated because Siemens Healthcare Diagnostics confirmed an ... Class III
Nov 28, 2012 Immunoradiometric assay. Device is an immunoradiometric assay designed for... The recall was initiated because Siemens Healthcare Diagnostics confirmed an ... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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