Recall Z-2192-2015 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Hardy Diagnostics
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
| Date | Jul 22, 2015 (initiated Jun 24, 2015) |
| Status | Terminated |
| Reason | Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. |
| Root cause | No Marketing Application |
| Action | The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form sta |
| Quantity | 1,500 |
| Distribution | Distributed to one U.S. customer in SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.