Instrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
Instrumentation Laboratory is recalling 1,414 units of HemoslL AcuStar HIT-lgG(PF-4) in vitro diagnostic reagents due to a potential for invalid calibration curves or negative mean bias of up to 47% with patient samples.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I due to a potential for invalid calibration curves or negative mean bias of up to 47% with patient samples. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Instrumentation Laboratory is recalling 1,414 units of HemoslL AcuStar HIT-lgG(PF-4) in vitro diagnostic reagents, Part Number 0009802028. The affected lots are B40006 (expiration date 01/16/2027) and B38063 (expiration date 11/01/2026). The product is distributed worldwide, including in the United States and various countries in Europe, Asia, and the Middle East.
The recall is being conducted because of a potential for invalid calibration curves or a negative mean bias of up to 47% with patient samples. This issue could affect the accuracy of the in vitro diagnostic results. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and laboratories that have purchased or received these specific lots of the HemoslL AcuStar HIT-lgG(PF-4) reagent should stop using the product and contact Instrumentation Laboratory for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- Manufacturer
- Instrumentation Laboratory
- Hazard
- Affected units
- 1,414
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)
- B38063 (11/01/2026).
Distribution
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