Recall Z-1333-2013 ยท JSI Culture Media, Selective And Differential
Becton Dickinson & Co.
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
| Date | May 16, 2013 (initiated Mar 11, 2013) |
| Status | Terminated |
| Reason | Microbiological media may be contaminated with bacteria. |
| Root cause | Material/Component Contamination |
| Action | BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and |
| Quantity | 521,160 total pieces (all three recalled products) |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.