The Recall Desk
Agency classClass IOur severity:Severity pendingFDA (Devices)·Z-0001-2027·Announced 2026-10-21

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

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

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

Product
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Manufacturer
Instrumentation Laboratory
Category
Medical Device — Devices
Affected units
434

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • B38062 (11/01/2026).

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Related recalls

Same manufacturer · Instrumentation Laboratory

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