Z-1095-2026Class II

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

Name: Z-1095-2026 The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the...
Creator: Instrumentation Laboratory
Published: 2025-12-11
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2025-12-11 / Open, Classified / root cause: sterility

FDA source

Instrumentation Laboratory began a recall of The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy on 2025-12-11. FDA classified it as Class II and gives the reason as "Potential for microbial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1095-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-11
Posted: 2026-01-15
Recalling firm: Instrumentation Laboratory Co.
Product: The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Product code: GFO Activated Partial Thromboplastin
Reason for recall: Potential for microbial contamination.
Root cause tag: sterility
FDA root cause: Under Investigation by 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.
Quantity in commerce: 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.
Product codes and lots: Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1095-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-15

Product code GFO

K060688Class IIHemosil SynthasilInstrumentation Laboratory CO / cleared 2006-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)