CanadaAsserachrom HPIA kits (catalogue 00615) with lot number 271288 are affected; identify the product by the Asserachrom HPIA name and lot 271288. The lot was recalled because about 5% of reagent 1 strips in that lot have a defect causing every well to produce negative results and causing low optical density readings for kit reference reagent 6 and control 2 (reagent 7b) similar to control 1 (reagent 7a), so values do not meet the assigned value sheet. Stop using lot 271288, dispose of remaining product according to local regulations, complete and return the acknowledgement form, and contact the manufacturer for additional information.
What's being recalled
Companies: Diagnostica Stago SAS, 3 Allee Theresa, Asnieres Sur Seine, France, 92600.
How to identify it
Affected products: Asserachrom® HPIA; Lot or serial number: 271288; Model or catalogue number: 00615
The hazard
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
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)