Recall Z-1095-2026
Instrumentation Laboratory · initiated December 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Codes / lots: Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
Reason for recall
Potential for microbial contamination.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1095-2026
- Initiated
- December 11, 2025
- Posted by FDA
- January 15, 2026
- Product code
- GFO – Activated Partial Thromboplastin
- Quantity
- 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 Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.
- Recalling firm
- Instrumentation Laboratory, Bedford, MA