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U.S. Department of Health and Human Services

Class 2 Device Recall HemosIL SynthASil

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 Class 2 Device Recall HemosIL SynthASilsee related information
Date Initiated by FirmDecember 11, 2025
Date PostedJanuary 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1095-2026
Recall Event ID 98166
510(K)NumberK060688 
Product Classification Activated partial thromboplastin - Product Code GFO
ProductThe product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Code Information Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
Recalling Firm/
Manufacturer		 Instrumentation Laboratory
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information ContactClient Services
752-379-2123
Manufacturer Reason
for Recall		Potential for microbial contamination.
FDA Determined
Cause 2		Under Investigation by firm
ActionWerfen 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.
Quantity in Commerce7,720 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GFO
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