Roche Molecular Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2403-2012)

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:

Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.

Product Classification:

Class II

Date Initiated: April 23, 2012

Date Posted: September 26, 2012

Recall Number: Z-2403-2012

Event ID: 62738

Reason for Recall:

When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.

Status: Terminated

Product Quantity: 1292 instruments

Code Information:

05666678001

Distribution Pattern:

Nationwide (USA) Distribution

Voluntary or Mandated:

Voluntary: Firm initiated