Roche Molecular Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2543-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

cobas Liat Analyzer, for in vitro diagnostic use.

Product Classification:

Class II

Date Initiated: July 24, 2015

Date Posted: September 9, 2015

Recall Number: Z-2543-2015

Event ID: 71785

Reason for Recall:

Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.

Status: Terminated

Product Quantity: 5 pieces

Code Information:

Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389

Distribution Pattern:

US Distribution to the states of :TX and NC.

Voluntary or Mandated:

Voluntary: Firm initiated