intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro

FDA device recall Z-0315-2025 · posted 2024-11-06 · Open, Classified

Recall details

Recalling firm

Biocare Medical, LLC

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.

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

PPM

Quantity affected

976

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.

Date initiated

2024-09-25

Date posted

2024-11-06

Location

Pacheco, CA