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Open, Classified

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

FDA Recall Z-0315-2025 · Posted 2024-11-06

Recalling FirmBiocare Medical, LLC
Recall StatusOpen, Classified
Product CodePPM
Date Initiated2024-09-25
Product Quantity976

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.

Firm Action

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 [email protected] Distributors were asked to send the customer notice to their customers. Questions regarding this recall notification may be forwarded to [email protected] On 12/12/2024, recall notices were sent to customers containing additional affected lots.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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