Hardy Diagnostics Recalls HardyCHROM VRE Agar Due to Lack of Clearance
Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a regulatory documentation issue (lack of 510(k) clearance) rather than a physical defect or contamination, which aligns with the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Hardy Diagnostics is recalling HardyCHROM VRE Agar-RSR (Catalog No. GA333, Lot No. H15055) because the product lacks FDA 510(k) clearance. The recalled items are chromogenic media plates used for stool pathogen screening.
The recall involves 1,500 units of the product, which were distributed to one U.S. customer in South Carolina. The product is packaged in 15x100mm monoplates with 10 plates per sleeve and has an expiration date of July 4, 2015.
Consumers and healthcare facilities should stop using the recalled product and contact Hardy Diagnostics for further instructions or a refund.
The recalled product
- Product
- HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
- Manufacturer
- Hardy Diagnostics
- Affected units
- 1,500
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.: G333 Lot No.: H15055
Distribution
Distributed in 1 state:
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