Diagnostic thromboplastin reagent recalled due to performance issues
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a diagnostic medical device with reported performance defects (imprecision, out-of-range quality controls) that could result in erroneous laboratory results. No illnesses or injuries have been reported, which per the rubric limits the severity to High.
Plain-English summary
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin (20 mL, Part number 0020301400), an in vitro diagnostic thromboplastin reagent used in clinical laboratories. The recall affects 5,828 kits distributed worldwide.
The company received customer reports of performance issues with affected lots, including increased imprecision, out-of-range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each reagent vial, there is a potential risk that erroneous test results could be reported.
Affected lots are N0705526 and N0806224. Within the United States, the product was distributed to clinical laboratories in Arizona, California, Iowa, Illinois, Kansas, Maine, Michigan, Indiana, Minnesota, North Carolina, New York, Oklahoma, South Carolina, and Virginia. Internationally, the product was distributed to Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea.
Laboratories should confirm that quality controls are performed and within range for each reagent vial before patient use. If quality controls fail or if replacement kits are needed, contact Instrumentation Laboratory.
The recalled product
- Product
- HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
- Manufacturer
- Instrumentation Laboratory
Distribution
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