Siemens Healthcare Diagnostics Inc 2023-09-06 Health serious FDA
Health · FDA · Recall #FDA-Z-2477-2023
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor… Recall
Issued September 6, 2023 · Siemens Healthcare Diagnostics Inc
In September 2023, Siemens Healthcare Diagnostics Inc recalled the epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
What you should do
- 1 Stop using epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Healthcare Diagnostics Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Siemens Healthcare Diagnostics Inc
- Category
- Health
- Recall date
- September 6, 2023
- Units affected
- Not reported
- Sold at
- US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribut
- Recall number
- FDA-Z-2477-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Healthcare Diagnostics Inc has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.