epoc BGEM Crea Test Card with epoc Host SW v3.37.3 recall
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Why was epoc BGEM Crea Test Card with epoc Host SW v3.37.3 recalled?
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023)
- Product
- epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 473 ea
- Distribution
- 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 distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam
- Recall date
- September 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)