Z-2463-2015 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
September 2, 2015
Initiation Date
July 9, 2015
Termination Date
November 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,820 (282 pk/10)

Product Description

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

Reason for Recall

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.

Distribution Pattern

Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.

Code Information

Cat no. G307 Lot no. H15155