Recall Z-2476-2023— Siemens Healthcare Diagnostics Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2023-06-01. It names one FDA 510(k) clearance: K200107. Product: epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1. Reason: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range..
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-01
- Firm location
- Norwood, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
epoc BGEM BUN 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.