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Biocare Medical, LLC - intelliPATH Universal HRP Detection Kit and ONCORE Pro DAB Chromogen - Class 2 Recall


Biocare Medical, LLC - intelliPATH Universal HRP Detection Kit and ONCORE Pro DAB Chromogen - Class 2 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.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]

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