FDA Recall
Terminated
Roche/Hitachi Tina-quant RF II; catalog # 3004902
Recall: Z-1030-03
·
Initiated September 30, 2002
Recall
- Recall Number
- Z-1030-03
- Event Number
- 26478
- Firm
- Roche Diagnostics Corp.
- FEI Number
- 1823260
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 30, 2002
- Posted
- July 19, 2003
- Terminated
- July 18, 2003
- Address
- 9115 Hague Road, Indianapolis, IN, 46250-0457
Description
Roche/Hitachi Tina-quant RF II; catalog # 3004902
Reason
Test results may exhibit a positive bias when plasma samples are used for the assay.
Action
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.
Distribution
United States
Quantity
480