Public recall detail

IP DAB Chromogen Kit 80 mL

2025-01-02

medium
Recall Safety notice
Quick summary

Quick summary: IP DAB Chromogen Kit 80 mL. Date: 2025-01-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: IP DAB Chromogen Kit 80 mL. Date: 2025-01-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBiocare Medical
ProductIP DAB Chromogen Kit 80 mL
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76792

Affected products

ProductIP DAB Chromogen Kit 80 mL
Lot100424 112823 071923 041624 091923
ModelIPK 5010 G80
Serial number100424 112823 071923 041624 091923
DescriptionIP DAB Chromogen Kit 80 mL

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceIndustry
CategoryHealth products - Medical devices - Pathology
CompaniesBiocare Medical 60 Berry Drive, Pacheco, California, United States, 94553
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76792
Background{}
CompaniesBiocare Medical 60 Berry Drive, Pacheco, California, United States, 94553
AudiencesIndustry
Source updated2025-01-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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