Z-2203-2016Class III

cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay

Name: Z-2203-2016 cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay
Creator: Roche Molecular Systems, Inc.
Published: 2016-05-17
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2016-05-17 / Terminated / root cause: labeling and UDI

FDA source

Roche Molecular Systems, Inc. began a recall of cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay on 2016-05-17. FDA classified it as Class III and gives the reason as "Kit labeled with the incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2203-2016
Classification: Class III
Status: Terminated
Initiated: 2016-05-17
Posted: 2016-07-13
Terminated: 2017-02-01
Recalling firm: Roche Molecular Systems Inc
Product: cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: Kit labeled with the incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: An Urgent Medical Device Recall (UMDR) notice (Customer Letter) was sent to the 35 individual affected customer sites by UPS on May 17 2016. Customers were asked to take the following actions: " Discontinue use of cobas Liat Influenza A/B Quality Control kit lot numbers 51222E, 60121H, 60201D, and 60229F, and discard them per your local regulations. " Complete the enclosed UMDC faxback form (6941-00-0516) and fax it to 1-844-449-8506. " File this UMDC for future reference.
Quantity in commerce: 194 distributed kits
Distribution: Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
Product codes and lots: Lot Numbers: 51222E, 60121H, 60201D, and 60229F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2203-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2203-2016	Class III	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-13

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)