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

FDA device recall Z-2209-2012 · posted 2012-08-15 · Terminated

Recall details

Recalling firm

Roche Molecular Systems, Inc.

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJF

Quantity affected

2,132 boxes

Distribution

Nationwide Distribution (USA).

Date initiated

2012-02-01

Date posted

2012-08-15

Date terminated

2013-07-16

Location

S Branchburg, NJ