FDAClass IIFebruary 21, 2018

Blastomyces dermatitidis Antiserum recall

Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

Why was Blastomyces dermatitidis Antiserum recalled?

The firm information that the product was reporting false positive results

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.

Product
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
Recalling firm
Gibson Laboratories LLC
Quantity
10/1 mL vials
Distribution
Distributed to the states of AL, AZ & MS.
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls