Date Initiated by Firm |
August 30, 2007 |
Date Posted |
December 12, 2007 |
Recall Status1 |
Terminated 3 on September 08, 2008 |
Recall Number |
Z-0459-2008 |
Recall Event ID |
38897 |
510(K)Number |
K033734
|
Product Classification |
Capillaries - Product Code JJF
|
Product |
Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **, Roche Diagnostics Corporation, Indianapolis 46250.(**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732 |
Code Information |
Lots 34979900, exp. 2/28/08; 35290100, exp. 2/28/08; 35293300 and 35296200 plus any capillaries received at the time of installation of the LightCycler instruments or systems**. (**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732) |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46250-0416
|
For Additional Information Contact |
800-526-1247
|
Manufacturer Reason for Recall |
False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal
|
FDA Determined Cause 2 |
Process design |
Action |
Consignees were notified by Urgent Medical Device Recall letter dated 8/30/07, to discontinue use of the 100uL capillaries, plus all of those received at installation, and to disposed of them per local guidelines. |
Quantity in Commerce |
119 boxes of 96 capillaries each |
Distribution |
Nationwide |
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 = JJF and Original Applicant = ROCHE DIAGNOSTICS CORP.
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