Siemens Healthcare Diagnostics Inc

Complete recall history across all FDA and CPSC categories — 77 total recalls

Siemens Healthcare Diagnostics Inc 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 (77)

FDA medical device enforcement actions by Siemens Healthcare Diagnostics Inc. Showing most recent 50.

Date Product Reason Class
Jul 7, 2025 epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias... Class II
Jun 26, 2025 RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/W... Class II
Mar 31, 2025 Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparin... Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care... Class II
Mar 19, 2025 epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens ... The occurrence of discrepant high pH results in samples introduced with highe... Class II
Mar 19, 2025 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens M... The occurrence of discrepant high pH results in samples introduced with highe... Class II
Sep 24, 2024 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias... Class II
May 17, 2024 Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... Siemens Healthineers has identified an issue with the RAPIDPoint500e system s... Class II
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended fo... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potentia... Class II
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potentia... Class II
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potentia... Class II
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potentia... Class II
Oct 19, 2023 epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that coul... Class II
Sep 26, 2023 RAPIDPOINT 500e Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetin... Class II
Sep 26, 2023 RAPIDPOINT 500 Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetin... Class II
Jun 1, 2023 epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Senso... There is potential for discrepant high glucose results in samples with glucos... Class II
Jun 1, 2023 epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N... There is potential for discrepant high glucose results in samples with glucos... Class II
Jun 1, 2023 epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sens... There is potential for discrepant high glucose results in samples with glucos... Class II
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc Host 10736387 e... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II
Aug 30, 2022 N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect ex... Class II
Aug 30, 2022 N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect ex... Class II
Jun 1, 2022 epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the qu... Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxem... Class II
Aug 28, 2020 Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative t... Sporadically inconsistent discrepant (low bias) glucose results on card lot 0... Class II
May 27, 2020 RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens M... The scanner is not confirming the integrity of read barcode data using the ch... Class II
May 29, 2019 Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro ... Potential for increased rate of false positive results and/or increased rate ... Class II
Apr 10, 2017 RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... Potential Patient Demographic Error with Blank Patient ID Field Class II
Sep 2, 2016 Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812,... Error in the value assignment for the Chloride calibrators in the RAPIDPoint ... Class III
Sep 2, 2016 Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, ... Error in the value assignment for the Chloride calibrators in the RAPIDPoint ... Class III
Aug 11, 2016 Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 1... There is a potential for the first and/or last name of one patient to be prin... Class II
Aug 11, 2016 RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 1... There is a potential for the first and/or last name of one patient to be prin... Class II
Aug 11, 2016 Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 103... There is a potential for the first and/or last name of one patient to be prin... Class II
Aug 11, 2016 Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): ... There is a potential for the first and/or last name of one patient to be prin... Class II
Aug 11, 2016 RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 1... There is a potential for the first and/or last name of one patient to be prin... Class II
Aug 11, 2016 RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 1... There is a potential for the first and/or last name of one patient to be prin... Class II
Aug 11, 2016 Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN... There is a potential for the first and/or last name of one patient to be prin... Class II
Jul 5, 2016 Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved ... Class III
Jun 22, 2016 Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... Software defect, where either an Above Assay Range or an inaccurate value cou... Class II
Nov 11, 2015 Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Nov 11, 2015 Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 251900... Class II
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 251900... Class II

View all 77 device recalls →

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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