Recall Z-0606-2018— Gibson Laboratories LLC
Class II · Terminated
Class II FDA medical device recall by Gibson Laboratories LLC, initiated 2017-01-20, terminated 2018-02-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.. Reason: The firm information that the product was reporting false positive results.
- Recalling firm
- Gibson Laboratories LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-20
- Terminated
- 2018-02-20
- Firm location
- Lexington, KY, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.