Recall Z-0011-2008 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Pml Microbiologicals Inc.
Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
| Date | Oct 10, 2007 (initiated Aug 17, 2007) |
| Status | Terminated |
| Reason | Marketed a regulated product without a 510(k). |
| Root cause | PMA |
| Action | Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product. |
| Quantity | 1205 plates distributed in US; 1040 distributed in Canada |
| Distribution | US, Puerto Rico, & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.