Public recall detail

HemosIL AcuStar HIT-IgG(PF4-H)

2026-10-15

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Health products Health product recall
Quick summary

Quick summary: HemosIL AcuStar HIT-IgG(PF4-H). Reason: Health product recall. Category: Health products. Date: 2026-10-15.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: HemosIL AcuStar HIT-IgG(PF4-H). Reason: Health product recall. Category: Health products. Date: 2026-10-15.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandINSTRUMENTATION LABORATORY CO.
ProductHemosIL AcuStar HIT-IgG(PF4-H)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82787

Affected products

ProductHemosIL AcuStar HIT-IgG(PF4-H)
LotB38062
Model0009800127
Serial numberB38062
DescriptionHemosIL AcuStar HIT-IgG(PF4-H)

Issue

A performance issue was identified with HemosIL AcuStar HIT-lgG(PF4-HL ) for the Lot B38062. This performance issue may result in a negative analytical bias and calibration-related failures. Therefore, the Lot B38062 is being recalled and removed from the market as a precautionary measure.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443
Recall date2026-09-29
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82787
Background{}
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443
AudiencesHealthcare
Source updated2026-10-15

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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