Device Recall Gibson Bioscience Blastomyces dermatitidis Antiserum 의 리콜

Recall

78731

Class 2

Z-0606-2018

2017-01-20

Terminated

United States

2018-02-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160239

The firm information that the product was reporting false positive results.

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 pepperson@gibsonlabs.com.