Roche Diagnostics Corp. BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.
Roche Diagnostics Corp. is recalling BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001. due to 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 f. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026