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[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

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductBlastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
Brand / manufacturerGibson Laboratories LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0606-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date20 January 2017
EAN / barcode10634853000039

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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