Roche Molecular Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2209-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 1, 2012

Date Posted: August 22, 2012

Recall Number: Z-2209-2012

Event ID: 62586

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

Status: Terminated

Product Quantity: 2,132 boxes

Code Information:

Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.

Distribution Pattern:

Nationwide Distribution (USA).

Voluntary or Mandated:

Voluntary: Firm initiated