Recall Z-0002-2027
- Recall number
- Z-0002-2027
- Event number
- 99843
- Firm
- Instrumentation Laboratory
- Firm FEI
- 1217183
- Product code
- LCO
- Status
- Open, Classified
- Initiated
- 2026-09-03
- Posted
- 2026-10-10
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K170854, K201570, K243374, K201311, K890633, K040293, K153137, K071781, K983379, K003767, K053559, K071255, K862774
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.