Recall Z-2203-2016— Roche Molecular Systems, Inc.

Name: FDA recall Z-2203-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-17

Class III · Terminated

Class III FDA medical device recall by Roche Molecular Systems, Inc., initiated 2016-05-17, terminated 2017-02-01. It names one FDA 510(k) clearance: K111387. Product: cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.. Reason: Kit labeled with the incorrect expiration date..

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-05-17
Terminated: 2017-02-01
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 Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.

Reason for recall

Kit labeled with the incorrect expiration date.

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