ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.
This recall has been terminated (originally issued July 4, 2006).
- Company
- Meridian Bioscience Inc
- Recall Initiated
- June 2, 2006
- Posted
- July 4, 2006
- Terminated
- February 16, 2012
- Recall Number
- Z-1203-06
- Quantity
- 704
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.
Distribution
Nationwide.
Lot / Code Info
Lot 712050.066, expiration date 2007-02-22 and Lot 712050.068, expiration date 2007-03-08.
Root Cause
Other
Action Taken
The recalling firm sent a recall letter dated 6/2/06 to their customers.
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