FDA recall Z-0606-2018

Gibson Laboratories LLC · Class II · device

Product

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

Reason for recall

The firm information that the product was reporting false positive results

Distribution

Distributed to the states of AL, AZ & MS.

Key facts

Status
Terminated
Initiation date
2017-01-20
Report date
2018-02-21
Termination date
2018-02-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lexington, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0606-2018