Class 2 Device Recall

• Date Initiated by Firm: February 15, 2005
• Date Posted: March 08, 2005
• Recall Status: Terminated on May 10, 2006
• Recall Number: Z-0573-05
• Recall Event ID: 31146
• 510(K)Number: K950104
• Product Classification: Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
• Product: BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
• Code Information: All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-526-1247
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJQ