Z-2543-2015Class II

cobas Liat Analyzer, for in vitro diagnostic use

Name: Z-2543-2015 cobas Liat Analyzer, for in vitro diagnostic use
Creator: Roche Molecular Systems, Inc.
Published: 2015-07-24
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2015-07-24 / Terminated / root cause: manufacturing process

FDA source

Roche Molecular Systems, Inc. began a recall of cobas Liat Analyzer, for in vitro diagnostic use on 2015-07-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2543-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-24
Posted: 2015-09-02
Terminated: 2015-12-23
Recalling firm: Roche Molecular Systems Inc
Product: cobas Liat Analyzer, for in vitro diagnostic use.
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Actions Required Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1. You will be contacted to return affected systems for immediate replacement. Complete the attached fax form and fax it to 1-317-521-4815. File this UMDR for future reference. Please contact the Roche Support Network Customer Support Center cobas Liat hotline at 1-800-800-5973, if you have questions about the information contained in this letter.
Quantity in commerce: 5 pieces
Distribution: US Distribution to the states of :TX and NC.
Product codes and lots: Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2543-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2543-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02

Product code OCC

K111387Class IILiat (Tm) Influenza a / B Assay, Liat (Tm) AnalyzerIquum, Inc. / cleared 2011-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)