Roche/Hitachi Tina-quant RF II; catalog # 3004902
This recall has been terminated (originally issued July 19, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- September 30, 2002
- Posted
- July 19, 2003
- Terminated
- July 18, 2003
- Recall Number
- Z-1030-03
- Quantity
- 480
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Test results may exhibit a positive bias when plasma samples are used for the assay.
Distribution
United States
Lot / Code Info
All lots
Root Cause
Other
Action Taken
A reagent bulletin dated 9/30/02 was sent to all users. Customers were instructed to discontinue the use of plasma samples with this reagent.
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