Official recall record
Asserachrom® HPIA
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-12-23
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.