medical HIGH RISK Updated 2026-10-21

Instrumentation Laboratory recalls HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in v

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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