The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring o
FDA device recall Z-1095-2026 · posted 2026-01-15 · Open, Classified
Recall details
- Recalling firm
- Instrumentation Laboratory
- Reason for recall
- Potential for microbial contamination.
- Action taken
- Werfen notified consignees on about 12/11/2025 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to check inventory for affected lots and destroy any on hand, document any destruction on the provided Urgent Mandatory Tracking Form, inform all laboratory personnel of the notification, forward the notification to all affected departments and locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form provided.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GFO
- Quantity affected
- 7,720 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Ko
- Date initiated
- 2025-12-11
- Date posted
- 2026-01-15
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOSIL SYNTHASIL (K060688) | Instrumentation Laboratory CO | 2006-04-13 |