Gibson Laboratories Recalls Blastomyces Antiserum Due to False Positives
Gibson Laboratories LLC is recalling Blastomyces dermatitidis Antiserum vials because the product was reporting false positive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves false positive results in diagnostic testing, which is a quality issue without reported injuries or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Gibson Laboratories LLC is recalling 10 vials of Blastomyces dermatitidis Antiserum, 1 mL each, Catalog 200265. The product is intended for the identification of systemic fungal pathogens. The recall was initiated because the firm reported that the product was reporting false positive results.
The affected lot is # 5072543 with an expiration date of 03/12/2021. The Unique Device Identifier (UDI) is 10634853000039. The product was distributed to the states of Alabama, Arizona, and Mississippi.
Healthcare facilities and laboratories that have received this product should stop using it and contact the manufacturer for instructions on return or disposal. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
- Manufacturer
- Gibson Laboratories LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 5072543 Exp Date 03/12/2021
- UDI : 10634853000039.
Distribution
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