Recall Z-1684-2025— Siemens Healthcare Diagnostics Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2025-03-19. It names one FDA 510(k) clearance: K200107. Product: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.. Reason: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n..
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-19
- 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 (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Reason for recall
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Data sourced from openFDA. This site is unofficial and independent of the FDA.