Prothrombin Time Reagent Recalled for Quality Control Failures
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin due to variable and out-of-specification quality control results. The manufacturer is removing all affected lots and providing customers with an alternative reagent.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with quality control failures affecting product performance. No illnesses or injuries reported; the hazard is potential rather than confirmed, meeting the criterion of 'risk-of-harm product where injury has not yet been reported.'
Plain-English summary
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin (Part No. 0020301400), a reagent used in prothrombin time testing, a common blood coagulation test performed in clinical and hospital laboratories.
The recall was initiated due to variable and out-of-specification quality control results detected in affected lots. While no illnesses or injuries have been reported, these QC failures could affect the accuracy and reliability of prothrombin time test results.
The recall affects 1,563 units distributed across the United States, including Arizona, California, Iowa, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia, and West Virginia. All in-date lots identified by UDI 08426950632887 are included in the recall. Instrumentation Laboratory is working with affected customers to remove the product from use and transition them to HemosIL RecombiPlasTin 2G, an alternative prothrombin time reagent.
The recalled product
- Product
- HemosIL ReadiPlasTin, Part No. 0020301400
- Manufacturer
- Instrumentation Laboratory
- Hazard
- qc-failure
- performance-issue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 08426950632887 All in-date lots are affected by this recall.
Distribution
Distributed nationwide across the United States.
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