CoaguChek PT test strips, sold in 12 pack.
This recall has been terminated (originally issued April 10, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- February 20, 2003
- Posted
- April 10, 2003
- Terminated
- November 10, 2003
- Recall Number
- Z-0720-03
- Quantity
- 11412 containers
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Discrepancy between INR and the % Quick displayed on the meter.
Distribution
Germany
Lot / Code Info
lot 533
Root Cause
Other
Action Taken
Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.
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