Recall Z-2543-2015— Roche Molecular Systems, Inc.

Name: FDA recall Z-2543-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-24

Class II · Terminated

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2015-07-24, terminated 2015-12-23. It names one FDA 510(k) clearance: K111387. Product: cobas Liat Analyzer, for in vitro diagnostic use.. Reason: 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..

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-24
Terminated: 2015-12-23
Firm location: Branchburg, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K111387 — LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZERIquum, Inc.·cleared 2011-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

cobas Liat Analyzer, for in vitro diagnostic use.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.