Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
This recall has been terminated (originally issued April 13, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- March 16, 2007
- Posted
- April 13, 2007
- Terminated
- June 12, 2008
- Recall Number
- Z-0736-2007
- Quantity
- 4,735
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.
Distribution
Nationwide.
Lot / Code Info
All Reagent Lots (including Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)
Root Cause
Other
Action Taken
A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
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