Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE — Class II medical device recall Z-0606-2018
Terminated recall by Gibson Laboratories LLC, reported 2018-02-21, distributed in AL, AZ, MS. The firm information that the product was reporting false positive results
| Recall number | Z-0606-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gibson Laboratories LLC, Lexington, KY, United States |
| Recall initiated | 2017-01-20 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-02-20 |
| Distributed | AL, AZ, MS |
| Quantity | 10 |
| UPC / GTIN / UDI-DI | 10634853000039 |
| Lot numbers | 5072543 |
| Model numbers | 200265 |
| Expiration dates | 2021-03-12 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0606-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.