Recall Z-0247-2007

Dade Behring, Inc. · initiated September 27, 2006

Terminated

Product

Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;

Codes / lots: Lot Numbers: 20071127, 20071128

Reason for recall

Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

FDA-determined cause: Other

Action taken

On 9/27/06, the firm initiated the recall and its notification was via phone calls and letters (FedEx''ed) explaining the reason for the recall and requesting the product be discarded.

Details

Recall number
Z-0247-2007
Initiated
September 27, 2006
Posted by FDA
December 5, 2006
Terminated
December 28, 2006
Product code
LIE – Reagent/Device, Inoculum Calibration
Quantity
828 units
Distribution
Worldwide, including USA, China, and Germany.
Recalling firm
Dade Behring, Inc., West Sacramento, CA

Official FDA recall record