Z-0574-05

BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001

Name: Z-0574-05 BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001
Creator: Roche Diagnostics Corp.
Published: 2005-02-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-02-15 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corp. began a recall of BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001 on 2005-02-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0574-05
Status: Terminated
Initiated: 2005-02-15
Posted: 2005-03-08
Terminated: 2006-05-10
Recalling firm: Roche Diagnostics GmbH
Product: BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
Product code: JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Distribution: Nationwide and Canada.
Product codes and lots: All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.

Product code JJQ

K953710Class IElx808 Automated Microplate ReadersBio-Tek Instruments, Inc. / cleared 1995-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)