Hardy Diagnostics Recalls Brain Heart Infusion Agar Plates Due to Contamination
Hardy Diagnostics is recalling specific lots of Brain Heart Infusion Agar plates because they failed to inhibit Staphylococcus aureus as required.
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 is classified as FDA Class II. The hazard involves a failure of the media to inhibit a specific bacterial strain, which poses a risk of inaccurate diagnostic results, but no direct patient injuries or illnesses are reported in the source text.
Plain-English summary
Hardy Diagnostics is recalling 820 units of Brain Heart Infusion Agar with 6 ug/ml Vancomycin (Catalog No. G14, Lot No. 472698). The product is manufactured in 15x100mm plates containing 18 ml of media. The recall was initiated after complaints were received reporting that Staphylococcus aureus (ATCC 29213) was not inhibited by the vancomycin in the agar, a condition known as breakthrough.
The affected product was distributed in the United States to California, Utah, Michigan, Puerto Rico, Indiana, Connecticut, Arizona, Georgia, Massachusetts, and Tennessee. No distribution outside the U.S. is reported. The product was manufactured on October 29, 2020, and expired on December 28, 2020.
Users of this product should stop using the affected lots immediately and contact Hardy Diagnostics for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
- 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)
- Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Distribution
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