FDA-Device2015-09-02Class II

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

Hardy Diagnostics
Hazard

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.

Sold states
Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
Affected count
2,820 (282 pk/10)
Manufactured in
1430 W Mccoy Ln, N/A, Santa Maria, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2463-2015

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