Recall MonitorHealth Products
IP DAB Chromogen Kit 80 mL
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Pathology
Product: IP DAB Chromogen Kit 80 mL
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| IP DAB Chromogen Kit 80 mL | 100424 112823 071923 041624 091923 | IPK 5010 G80 |
Issue
Biocare Medical initially became aware of an issue where certain kits containing the DAB Chromogen Buffer Lots were not performing as expected, producing reduced or weak to no staining. The initial recall in Sept 2024 did not include product distributed in Canada. Following further investigation, Biocare is expanding the scope of the recall to include additional kits containing the identified lots of DAB Buffer, including product distributed in Canada. Recall Start Date: December 19, 2024