Device product
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.
Z-1332-2013
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-1332-2013
Official wording
Reason: Microbiological media may be contaminated with bacteria.
Code information: Model number 221239: lot 2348199 with expiration date 4/5/13; and model number 221261: lot 2348208 with expiration date 3/22/13, lot 2355145 with expiration date 4/2/13, lot 2339019 with expiration date 4/5/13, lot 2348157 with expiration date 4/6/13, lot 2361011 with expiration date 4/6/13, lot 2348202 ,with expiration date 4/6/13, lot 2348108 with expiration date 4/12/13, lot 2348074 with expiration date 4/19/13, and lot 3038371 with expiration date 5/28/13
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.