Z-2463-2015 Class II Terminated
FDA device recall Z-2463-2015 was initiated by Hardy Diagnostics on July 9, 2015 and is designated Class II. 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. The recall status is terminated (terminated November 10, 2015). Affected quantity: 2,820 (282 pk/10).
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