Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Read the official notice →- Date
- 2023-09-06
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Classification
- Class II
- Units
- US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Siemens Healthcare Diagnostics recalls
- 2023-12-27
USSiemens Healthcare Diagnostics Inc recalls epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX),…
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS…
- 2023-12-06
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPOINT 500 Blood Gas System
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The…
FDA · DeviceSiemens Healthcare Diagnostics IncDomestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola,…Official notice → - 2023-10-11
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
- 2023-09-06
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl…
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2),…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay VietnamOfficial notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human…
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Country Albania Algeria Argentina Australia Austria…Official notice → - 2023-08-30
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the…
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA,…Official notice →
Other drugs & medical recalls in the United States
- 2023-09-06
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis…
A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a…
- US
Olympus Corporation of the Americas recalls Visera Hysterovideoscope Olympus HYF Type V
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL,…Official notice → - US
Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery…
FDA · DeviceEdwards Lifesciences, LLCInternational distribution to the countries of Austria, Belgium, Switzerland,…Official notice → - US
Alphatec Spine, Inc. recalls LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and…
Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by…
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl…
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2),…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay VietnamOfficial notice → - US
Skytron, LLC recalls GS70H Salus Surgical Table, Product Code 18-071-70
When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to…
FDA · DeviceSkytron, LLCWorldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL,…Official notice →