Medical device recalls Moderate risk

Hardy Diagnostics recalls HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/…

Recall date
July 9, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2463-2015
FDA classification
Class II
Brand / firm
Hardy Diagnostics
Sold / distributed
Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.

Why it was recalled

Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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