Hardy Diagnostics Recalls FB Broth Due to Potential Contamination
Hardy Diagnostics is recalling FB Broth (Lot 15231) because of potential Burkholderia fungorum contamination. The product was distributed in California, Wisconsin, Maryland, and Utah.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device (laboratory reagent) with a potential contamination hazard (Burkholderia fungorum) where no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Hardy Diagnostics is recalling FB Broth, Catalog No. K31, Lot No. 15231. The recall is being conducted because of potential contamination with Burkholderia fungorum. FB Broth is a fastidious bacteria broth used for the enriched cultivation of specific bacteria from clinical specimens.
The affected product was distributed in the United States to the states of California, Wisconsin, Maryland, and Utah. The source text does not specify the exact number of units recalled or the specific facilities where the product was distributed.
Consumers and healthcare facilities should check their inventory for FB Broth with Catalog No. K31 and Lot No. 15231. If found, the product should be stopped from use and returned to the supplier or the recalling firm, Hardy Diagnostics, in accordance with their instructions.
The recalled product
- Product
- FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
- Manufacturer
- Hardy Diagnostics
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 (1)
- Cat. no. K31 Lot no.15231
Distribution
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