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Open, Classified

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

FDA Recall Z-1095-2026 · Posted 2026-01-15

Recalling FirmInstrumentation Laboratory
Recall StatusOpen, Classified
Product CodeGFO
Date Initiated2025-12-11
Product Quantity7,720 units

Reason for Recall

Potential for microbial contamination.

Firm Action

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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060688HEMOSIL SYNTHASILInstrumentation Laboratory CO · 2006-04-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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