Hardy Diagnostics Recalls HardyCHROM MRSA In Vitro Diagnostic Plates
Hardy Diagnostics is recalling HardyCHROM MRSA plates due to a potential quality control issue involving the MSSA strain.
What this means for you
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, but the source text describes a potential quality control issue without reporting any hospitalizations, significant injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Hardy Diagnostics is recalling HardyCHROM MRSA in vitro diagnostic plates, specifically Catalog No. G307 and Lot No. H15155. The recall is being conducted due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) quality control strain, ATCC 29213, on the identified lot.
The affected product is packaged as 15x100mm monoplates, with 10 plates per sleeve. The total quantity involved in the recall is 2,820 units. The product was distributed in the states of Virginia, Pennsylvania, New York, New Jersey, Illinois, Ohio, and Maryland.
Consumers and healthcare facilities should check their inventory for the specific lot number and expiration date listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or the manufacturer in accordance with their instructions.
The recalled product
- Product
- HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
- Manufacturer
- Hardy Diagnostics
- 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 (1)
- Cat no. G307 Lot no. H15155
Distribution
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