Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML micr
FDA device recall Z-0014-2008 · posted 2007-10-10 · Terminated
Recall details
- Recalling firm
- Pml Microbiologicals Inc.
- Reason for recall
- Plates manufactured without vancomycin. Possibility for false resistant results.
- Action taken
- On 4/23/07 the firm began contacting customers via fax and telephone.
- Root cause
- Other
- Status
- Terminated
- Product code
- JSO
- Quantity affected
- 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
- Date initiated
- 2007-04-23
- Date posted
- 2007-10-10
- Date terminated
- 2011-06-07
- Location
- Wilsonville, OR
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