Hardy Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-2463-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 9, 2015

Date Posted: September 2, 2015

Recall Number: Z-2463-2015

Event ID: 71804

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.

Status: Terminated

Product Quantity: 2,820 (282 pk/10)

Code Information:

Cat no. G307 Lot no. H15155

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated