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/ 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 2 |
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
|
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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.
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