FDA recall, , Moderate risk
Instrumentation Laboratory Coagulation Testing Reagents
The product has potential for microbial contamination.
Summary by Recall Canary from the FDA notice
What happened
Instrumentation Laboratory of Bedford, Massachusetts, began a recall on December 11, 2025, of 7,720 units of a product used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy, due to potential for microbial contamination.
The recall was added to the FDA's Enforcement Report and classified on January 15, 2026, and was in the FDA's weekly enforcement report on January 21, 2026.
Distribution was worldwide, including 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
- UDI-DI
- 0020006800
- 08426950078920
- Lot code
- N1136730
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Florida, Illinois, Minnesota, Mississippi, Nebraska, Ohio, Texas, Wisconsin and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.
- Company
- Instrumentation LaboratoryBedford, Massachusetts
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98166
- Recall number
- Z-1095-2026
- Quantity recalled
- 7,720 units
All recalls from Instrumentation Laboratory
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
