CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
This recall has been terminated (originally issued April 11, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- February 28, 2007
- Posted
- April 11, 2007
- Terminated
- June 13, 2007
- Recall Number
- Z-0737-2007
- Quantity
- 10
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
Distribution
Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
Lot / Code Info
Lots 469A and 475A; exp. 6/30/2008.
Root Cause
Other
Action Taken
All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
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