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U.S. Department of Health and Human Services

Class 2 Device Recall intelliPATH" Universal HRP Detection Kit and ONCORE Pro DAB Chromogen

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 Class 2 Device Recall intelliPATH" Universal HRP Detection Kit and ONCORE Pro DAB Chromogensee related information
Date Initiated by FirmSeptember 25, 2024
Date PostedNovember 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0315-2025
Recall Event ID 95481
Product Classification General purpose reagent - Product Code PPM
ProductintelliPATH 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
Code Information 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)
FEI Number 3004140393
Recalling Firm/
Manufacturer		 Biocare Medical, LLC
60 Berry Dr
Pacheco CA 94553-5601
For Additional Information Contact
925-603-8002
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce976
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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