Z-2209-2012Class II

COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold...

Name: Z-2209-2012 COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold...
Creator: Roche Molecular Systems, Inc.
Published: 2012-02-01
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2012-02-01 / Terminated / root cause: manufacturing process

FDA source

Roche Molecular Systems, Inc. began a recall of COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep... on 2012-02-01. FDA classified it as Class II and gives the reason as "Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the...". 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-2209-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-01
Posted: 2012-08-15
Terminated: 2013-07-16
Recalling firm: Roche Molecular Systems Inc
Product: COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
Product code: JJF Analyzer, Chemistry, Micro, For Clinical Use
Reason for recall: Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if the issue occurs, but samples in proce
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 1/17/2012 an "Analyzer Bulletin" notification was sent to Roche affiliates and on 2/1/2012 an "Analyzer Bulletin" notification was sent to all affected US Consignees. The notification described the product issue and provided recommended actions. Customers were referred to Roche Technical Support at 800-526-1247 for questions.
Quantity in commerce: 2,132 boxes
Distribution: Nationwide Distribution (USA).
Product codes and lots: Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2209-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2209-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-15

Product code JJF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)