Device product
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
Z-1333-2013
Product summary
- Event
- Event 64883
- Status
- Terminated
- Classification
- Class II
- Quantity
- 521,160 total pieces (all three recalled products)
- Official record key
device-enforcement:Z-1333-2013
Official wording
Reason: Microbiological media may be contaminated with bacteria.
Code information: Model number 221291: lot 2355138 with expiration date 3/6/13, lot 2355164 with expiration date 3/8/13
Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.
Derived failure modes
-
Unknown
Microbiological media may be contaminated with bacteria.