epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Softw
FDA device recall Z-1685-2025 · posted 2025-04-29 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
- Action taken
- Consignees were sent an Urgent Medical Device Correction notice dated March 2025. The notification instructs consignees to review the provided notice with their medical director to determine the appropriate course of action. If affected devices were further distributed consignees are asked to forward the recall notification. Consignees are to return the provided Field Correction Effectiveness Check form within 7 days of receipt. The firm recommends that consignees stop injecting the sample as soon as the audio/visual cues are presented to minimize the potential for erroneous pH results. The current affected software expires on 06/10/25 and the upgrade will include a correction for this issue. Consignees are to retain the recall notification with their manual or near the system for reference. Consignees with questions can call the Siemens Healthineers Technical Solutions Center at 877-229-3711.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- CHL
- Quantity affected
- 5,207 units
- Distribution
- Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Cro
- Date initiated
- 2025-03-19
- Date posted
- 2025-04-29
- Location
- Norwood, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| epoc Blood Analysis System (K200107) | Epocal, Inc. | 2020-06-05 |