Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
FDA Recall Z-0014-2008 · Posted 2007-10-10
Recalling FirmPml Microbiologicals Inc.
Recall StatusTerminated
Product CodeJSO
Date Initiated2007-04-23
Date Terminated2011-06-07
Product Quantity640 total plates, 320 per lot (lot 229957-1 was dist only in Canada; lot 229958-1 was dist in the US and Canada)
Reason for Recall
Plates manufactured without vancomycin. Possibility for false resistant results.
Firm Action
On 4/23/07 the firm began contacting customers via fax and telephone.
Root Cause
Other
Distribution Pattern
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 distribution center.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.