Z-0459-2008

Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers...

Name: Z-0459-2008 Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers...
Creator: Roche Diagnostics Corp.
Published: 2007-08-30
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-08-30 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corp. began a recall of Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received... on 2007-08-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0459-2008
Status: Terminated
Initiated: 2007-08-30
Posted: 2007-12-12
Terminated: 2008-09-08
Recalling firm: Roche Diagnostics GmbH
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
Product code: JJF Analyzer, Chemistry, Micro, For Clinical Use
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
Root cause tag: manufacturing process
FDA 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 in commerce: 119 boxes of 96 capillaries each
Distribution: Nationwide
Product codes and lots: 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)

Product code JJF

K033734Class ILightcycler Instrument Version 1.2Roche Diagnostics Corp. / cleared 2003-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)