Roche Molecular Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0614-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland

Product Classification:

Class II

Date Initiated: October 11, 2012

Date Posted: January 2, 2013

Recall Number: Z-0614-2013

Event ID: 63814

Reason for Recall:

Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.

Status: Terminated

Product Quantity: 7 units

Code Information:

CAP 394436 to 394663

Distribution Pattern:

Distributed in the states of GA, CA, NC, and MN.

Voluntary or Mandated:

Voluntary: Firm initiated