Z-2216-2016Class II

cobas Liat Analyzer

Name: Z-2216-2016 cobas Liat Analyzer
Creator: Roche Molecular Systems, Inc.
Published: 2016-05-09
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2016-05-09 / Terminated

FDA source

Roche Molecular Systems, Inc. began a recall of cobas Liat Analyzer on 2016-05-09. FDA classified it as Class II and gives the reason as "Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2216-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Posted: 2016-07-15
Terminated: 2021-03-24
Recalling firm: Roche Molecular Systems Inc
Product: cobas Liat Analyzer
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
FDA root cause: Under Investigation by firm
Action: Customers were notified of the recall via phone and email sent on 5/9/2016. They were instructed to take the following actions: Immediately discontinue use of the affected instruments until they have been reworked by a Roche Field Engineering Specialist. A Roche representative will contact you to schedule this service. Complete the attached fax form and fax it to 1-317-521-4815. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center 1-800-800-5973 if you have questions.
Quantity in commerce: 2
Distribution: Distributed in NC and WA.
Product codes and lots: US-IVD: M1-E-00383 & M1-E-00434

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2216-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2216-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-15

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)