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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 15, 2005
Date Posted March 08, 2005
Recall Status1 Terminated 3 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/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
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 2
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 and Original Applicant = BIO-TEK INSTRUMENTS, INC.