FDA Medical Device Recalls (openFDA)
Gibson Laboratories LLC: Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
- Recall number
- Z-0606-2018
- Recalling firm
- Gibson Laboratories LLC
- Product
- Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
- Status
- Terminated
- Initiated
- 2017-01-20
- Posted
- not on file
- Terminated
- 2018-02-20
- Reason
- The firm information that the product was reporting false positive results
- Root cause
- Mixed-up of materials/components
- 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 pepperson@gibsonlabs.com.
- Quantity
- 10/1 mL vials
- Distribution
- Distributed to the states of AL, AZ & MS.
- Lot, serial or model codes
- Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LSI
- Firm FEI
- 1050138
- Firm city
- Lexington
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28