Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 0333
FDA device recall Z-0459-2008 · posted 2007-12-12 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JJF
- Quantity affected
- 119 boxes of 96 capillaries each
- Distribution
- Nationwide
- Date initiated
- 2007-08-30
- Date posted
- 2007-12-12
- Date terminated
- 2008-09-08
- Location
- Indianapolis, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734) | Roche Diagnostics Corp. | 2003-12-17 |