PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 2, 2015 Initiated: July 9, 2015 #Z-2463-2015

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.

Details

Recalling Firm
Hardy Diagnostics
Units Affected
2,820 (282 pk/10)
Distribution
Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
Location
Santa Maria, CA

Frequently Asked Questions

What product 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. Recalled by Hardy Diagnostics. Units affected: 2,820 (282 pk/10).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2463-2015.