Recall Z-0459-2008 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Roche Diagnostics Corp.
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 Instrum
| Date | Dec 12, 2007 (initiated Aug 30, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 119 boxes of 96 capillaries each |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 Roche Diagnostics Corp., Dec 17, 2003 |