← All recalls
Medical Device

HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)

Recall date: 2026-10-21 · Source: FDA_DEVICE
Brand / Firm
Instrumentation Laboratory
Product
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Reason for recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Units affected
1,414 units
Description
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
View official recall notice →