BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
Hazard
The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
What You Should Do
Remedy
Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.
Affected by this recall?
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Products
BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
- Brand
- Roche Diagnostics Corp.
- UPC
- All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.