epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Reported: September 6, 2023 Initiated: June 1, 2023 #Z-2477-2023
Product Description
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Reason for Recall
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 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
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 473 ea.
Why was this product recalled? ▼
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2477-2023.
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