Siemens Healthcare Diagnostics Inc
Norwood, MA
This page shows every FDA and USDA recall linked to Siemens Healthcare Diagnostics Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
77
Total Recalls
2009
First Recall
2025
Most Recent
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Aug 5, 2025
· Device
Open, Classified
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Jul 31, 2025
· Device
Open, Classified
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; e...
Apr 29, 2025
· Device
Open, Classified
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382;...
Apr 29, 2025
· Device
Open, Classified
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Apr 25, 2025
· Device
Open, Classified
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Nov 1, 2024
· Device
Open, Classified
Software version 5.3 in:
RAPIDPoint 500e Blood Gas System (USA)
Siemens Material Number: 11416751
RAPIDPoin...
Jun 26, 2024
· Device
Open, Classified
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is...
Dec 21, 2023
· Device
Open, Classified
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is de...
Dec 21, 2023
· Device
Open, Classified
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is de...
Dec 21, 2023
· Device
Open, Classified
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 114...
Dec 21, 2023
· Device
Open, Classified
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is de...
Dec 21, 2023
· Device
Open, Classified
RAPIDPOINT 500e Blood Gas System
Dec 1, 2023
· Device
Open, Classified
RAPIDPOINT 500 Blood Gas System
Dec 1, 2023
· Device
Open, Classified
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configurati...
Aug 28, 2023
· Device
Open, Classified
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Aug 28, 2023
· Device
Open, Classified
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Aug 28, 2023
· Device
Open, Classified
epoc Host 2 as follows:
Product SMN
epoc NXS Host, US 11413475
epoc NXS Host, EU 1141349...
Mar 3, 2023
· Device
Open, Classified
epoc Host 2 as follows:
Product SMN
epoc Host 10736387
epoc Host 2, Canada 10736388
epoc Hos...
Mar 3, 2023
· Device
Open, Classified
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of...
Jun 1, 2022
· Device
Open, Classified
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized...
Aug 28, 2020
· Device
Terminated
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
May 27, 2020
· Device
Terminated
Stratus CS Acute Care cTNI TestPak, SMN 10445071
Product Usage:
In vitro diagnostic test for the measurement...
May 29, 2019
· Device
Terminated
RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory env...
Apr 10, 2017
· Device
Terminated
Siemens RAPIDPoint 405 Measurement Cartridge
Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
Sep 30, 2016
· Device
Terminated
Siemens RAPIDPoint 400 Measurement Cartridge
Siemens SMN numbers:10329756, 10341161
Sep 30, 2016
· Device
Terminated
Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A
The RAPIDPoint 500 sy...
Aug 19, 2016
· Device
Terminated
Siemens RAPIDLab 1240 Blood Gas Analyzer
Siemens Material Number (SMN):
10321840, 10491392
Aug 11, 2016
· Device
Terminated
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili
Siemens Material Number (SMN):
10282093, 10310464, 10314817, 1...
Aug 11, 2016
· Device
Terminated
RAPIDLab 1265 Blood Gas Analyzer
Siemens Material Number (SMN):
10321852, 10470366, 10491395
Aug 11, 2016
· Device
Terminated
Siemens RAPIDPoint 500 Blood Gas Analyzer
Siemens Material Number (SMN):
10492730, 10696855, 10696857, 10697...
Aug 11, 2016
· Device
Terminated
Siemens RAPIDPoint 400 Blood Gas Analyzer
Siemens Material Number (SMN):
10291507,10314585, 10318899,10321239,...
Aug 11, 2016
· Device
Terminated
RAPIDLab 1245 Blood Gas Analyzer
Siemens Material Number (SMN):
10321844, 10337179, 10491393
Aug 11, 2016
· Device
Terminated
RAPIDLab 1260 Blood Gas Analyzer
Siemens Material Number (SMN):
10321846, 10491394
Aug 11, 2016
· Device
Terminated
Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument
that measures certain analytes in b...
Jun 22, 2016
· Device
Terminated
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP m...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-b...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stra...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care MYO DilPak
Catalog Number: CMYO-D
SMN:10445081
in vitro diagnostic
Jan 7, 2016
· Device
Terminated
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in hepa...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP met...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acu...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparin...
Jan 7, 2016
· Device
Terminated
Siemens Acute Care DDMR TestPak
Catalog Number: CDDMRE
SMN: 10701511
in vitro diagnostic
Jan 7, 2016
· Device
Terminated
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests
Part Number: 10491447
Product Usage:
The RAP...
Sep 24, 2015
· Device
Terminated
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests
Part Number: 10844813
Product Usage:
The RAP...
Sep 24, 2015
· Device
Terminated
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests)
Part Number: 10491449
Product Usage:
The RAP...
Sep 24, 2015
· Device
Terminated
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests
Part Number: 10491448
Product Usage:
The RAP...
Sep 24, 2015
· Device
Terminated