—#54521

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

FDA product code: JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K033734
Affected lot / code info: 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)

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2007-08-30
Posted by FDA: 2007-12-12
Terminated: 2008-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #54521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.