—#37361

Product

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

FDA product code: JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K953710
Affected lot / code info: All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide and Canada.

Timeline

Recall initiated: 2005-02-15
Posted by FDA: 2005-03-08
Terminated: 2006-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.