Health Products

HemosIL AcuStar HIT-IgG(PF4-H)

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: HemosIL AcuStar HIT-IgG(PF4-H)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
HemosIL AcuStar HIT-IgG(PF4-H)B380620009800127

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.

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