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Recall Observatory FDA recall evidence

Device 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

Z-2463-2015

July 09, 2015

Class II

Product summary

Firm
Hardy Diagnostics
Event
Event 71804
Status
Terminated
Classification
Class II
Quantity
2,820 (282 pk/10)
Official record key
device-enforcement:Z-2463-2015

Official wording

Reason: 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.

Code information: Cat no. G307 Lot no. H15155

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.