Recall Monitor
Health Products

Asserachrom® HPIA

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Immunology
Product: Asserachrom® HPIA
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

Lot or serial numberAffected productsModel or catalogue number
271288Asserachrom® HPIA00615

Issue

After receiving three customer complaints (from outside Canada and the US), Stago investigated and confirmed that approximately 5% of reagent 1 strips had a defect for Asserachrom® HPIA lot 271288. When the defect is present, every well in the impacted strip produces negative results. Kit reference reagent 6 and control 2 (reagent 7b) produce low optical density (OD) readings, similar to those of control 1 (reagent 7a). As a result, these values will not meet the requirements specified in the assigned value sheet for the lot and must not be used. consignee actions: Stop using lot 271288 and dispose of all remaining product according to local regulations. Complete, sign, and return acknowledgement form.

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