Recalls
Werfen recalls HemosIL HIT test lots over false-negative risk
The FDA says affected test lots may produce false-negative results that delay recognition of heparin-induced thrombocytopenia.
Instrumentation Laboratories, also known as Werfen, is removing affected lots of its HemosIL AcuStar HIT-IgG(PF4-H) test after identifying a performance issue that could lead to false-negative results. The FDA identified the recall as the most serious type and said the results could delay recognition of heparin-induced thrombocytopenia (HIT).
The affected lots are B40005, B40006, B38062, and B38063. Werfen’s investigation found performance variability, with negative bias of 20-35%, which may not be detected through routine calibration and quality control testing. Results could be reported below the assay cut-off of 1.00 U/mL. As of September 3, Werfen reported no serious injuries or deaths associated with the issue.
The FDA says customers should identify and destroy the affected lots. Laboratories and treating clinicians should decide whether to review previous patient results, arrange follow-up, or repeat testing according to local procedures and clinical judgment.
