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Terminated

Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

FDA Recall Z-0606-2018 · Posted None

Recalling FirmGibson Laboratories LLC
Recall StatusTerminated
Product CodeLSI
Date Initiated2017-01-20
Date Terminated2018-02-20
Product Quantity10/1 mL vials

Reason for Recall

The firm information that the product was reporting false positive results

Firm Action

On January 20, 2017, the firm sent Urgent Medical Device Recall notification letter and response form to their customers. The letter identified the affected and the reason for the recall. Users are instructed not to use any Blastomyces dermatitidis (catalog # 200265) that they may have in inventory and to quarantine any affected product. Return any affected product per the instructions provided; and, complete and return the attached acknowledgement form. Questions regarding this recall should be directed to Penny Epperson, Quality Manager, at 859-303-5169 or [email protected].

Root Cause

Mixed-up of materials/components

Distribution Pattern

Distributed to the states of AL, AZ & MS.

Official Source

View FDA Recall →

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

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