Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- December 29, 2003
- Posted
- July 20, 2004
- Terminated
- February 20, 2004
- Recall Number
- Z-0333-04
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Distribution
United States.
Lot / Code Info
All units.
Root Cause
Other
Action Taken
A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.
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