Recall Z-0014-2008 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Pml Microbiologicals Inc.
Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
| Date | Oct 10, 2007 (initiated Apr 23, 2007) |
| Status | Terminated |
| Reason | Plates manufactured without vancomycin. Possibility for false resistant results. |
| Root cause | Other |
| Action | On 4/23/07 the firm began contacting customers via fax and telephone. |
| Quantity | 640 total plates, 320 per lot (lot 229957-1 was dist only in Canada; lot 229958-1 was dist in the US and Canada) |
| Distribution | lot #229957-1: 120 plates were distributed to 9 Canadian consignees; 200 plates were shipped, quarantined, and destroyed at the Canadian distribution center. lot #229958-1: 110 plates were distributed to 9 US consignees; 210 plates were shipped, quarantined, and destroyed at the Canadian distribu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.