Biocare Medical Recalls IHC Kits Due to Potential Staining Failure
Biocare Medical is recalling specific IHC kits containing DAB Buffer because they may produce weak or no staining, leading to test failure.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to test failure requiring repetition, with no reported injuries or illnesses, fitting the 'voluntary precautionary' or low-risk defect criteria.
Plain-English summary
Biocare Medical, LLC is recalling specific Immunohistochemistry (IHC) kits that contain DAB Buffer. The affected products include the intelliPATH Universal HRP Detection Kit, ONCORE Pro DAB Chromogen, IP DAB Chromogen Kit, and Folate Receptor alpha IHC Assay Kit. The recall involves 976 units distributed nationwide in 19 states and Puerto Rico.
The recall is being issued because the kits may produce weak to no staining during manual or automated IHC staining protocols. This defect may lead to test failure, requiring the test to be repeated. The source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities and laboratories should stop using the affected kits and contact Biocare Medical for further instructions. Specific lot numbers and reference codes for the affected products are listed in the official recall notice.
The recalled product
- Product
- intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer,
- Manufacturer
- Biocare Medical, LLC
- Hazard
- Affected units
- 976
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- REF/UDI-DI/Kit Lot(DAB Lot): IPK5011G80/00847627009005/042324(012424A)
- 060523(051823A)
- 082923(062923A)
- 011624(072723A)
- 042324(012424A)
- 080524(032624A)
- OPRI6056KT180/00847627024985/020624(111623A)
- 032224(111623A-3)
- IPK5010G80/00847627008992/071923(051823A)
- 091923(081023A)
- 112823(101923A)
- 100424(011524A)
- 041624(022624A)
- OPRI6056KT180/00847627024985/071924(061824A)
- IPI4006KG10/00847627008985/080323(062923A)
- 102723(081023A)
Distribution
Related recalls
Same manufacturer · Biocare Medical, LLC
See all →- HighBiocare Medical IntelliPath FLX Automated Staining Instrument Recall
FDA (Devices) · 2021-04-07
- HighBiocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure
FDA (Devices) · 2020-06-17
- ModerateBiocare Medical Recalls URO-3 Triple Stain Kits Due to Component Mislabeling
FDA (Devices) · 2018-09-26
- ModerateBiocare Medical Recalls Vulcan Fast Red Chromogen Kit Due to Stability Issue
FDA (Devices) · 2018-07-11
- ModerateBiocare Medical Recalls Mislabeled Mach 4 Mouse Probe Vials
FDA (Devices) · 2016-04-27
Same hazard · test failure
See all →- ModerateGSP Neonatal GALT Kit in vitro diagnostic test equipment
FDA (Devices) · 2026-07-15
- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighDiagnostic analyzer software may fail to alert users to expired reagents
FDA (Devices) · 2025-01-29
- HighCepheid Xpert Xpress Strep A test kits may produce invalid results
FDA (Devices) · 2023-11-08
- ModerateCOVID-19 Diagnostic Test Kits Recalled Due to Performance Reliability Issues
FDA (Devices) · 2023-08-02