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, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
This recall is currently active, issued November 6, 2024. It was issued by Biocare Medical, Llc.
- Company
- Biocare Medical, Llc
- Recall Initiated
- September 25, 2024
- Posted
- November 6, 2024
- Recall Number
- Z-0315-2025
- Quantity
- 976
- Firm Location
- Pacheco, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
Distribution
US Nationwide distribution in the states of MA, AZ, CT, NY, FL, NC, IN, IL, MO, CO, TX, CA, MI, PR, PA, MD, AL, OH, KY.
Lot / Code Info
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)
Root Cause
Nonconforming Material/Component
Action Taken
On 9/25/24, recall notices were sent to customers and distributors who were asked to do the following: 1) Locate any affected kits in your possession and discontinue use. 2) Share this notification with all users within your facility and network to ensure all personnel who may use the kits are aware of this recall. 3) Discard any product remaining in your possession. 4) Complete and return the Response Form via email to productcompliance@biocare.net Distributors were asked to send the customer notice to their customers. Questions regarding this recall notification may be forwarded to productcompliance@biocare.net On 12/12/2024, recall notices were sent to customers containing additional affected lots.