Recall Z-2276-2015 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Hardy Diagnostics
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
| Date | Jul 29, 2015 (initiated Jun 26, 2015) |
| Status | Terminated |
| Reason | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth 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 discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within exp |
| Quantity | 5,940 (5940 pk/10) |
| Distribution | U.S. Nationwide Distribution and the country of: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.