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Instrumentation Laboratory recalls HemoslL AcuStar HIT-lgG

What should I do?

Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.

What's the hazard?

Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

What's affected

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

Read the official FDA Enforcement Report ↗