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Medical Device

HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic

Recall date: 2026-10-21 · Source: FDA_DEVICE
Brand / Firm
Instrumentation Laboratory
Product
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Reason for recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Units affected
434 units
Description
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
View official recall notice →