[Recalled] Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens. — The firm information that the product was reporting false positive results | FDA 2
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens. |
|---|---|
| Brand / manufacturer | Gibson Laboratories LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0606-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 January 2017 |
| EAN / barcode | 10634853000039 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The firm information that the product was reporting false positive results
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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