Recall Z-2463-2015 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Hardy Diagnostics
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
| Date | Aug 26, 2015 (initiated Jul 9, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be r |
| Quantity | 2,820 (282 pk/10) |
| Distribution | Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102922 | HARDYCHROM MRSA Hardy Diagnostics, May 4, 2011 |