cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
FDA Recall Z-2203-2016 · Posted 2016-07-13
Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOCC
Date Initiated2016-05-17
Date Terminated2017-02-01
Product Quantity194 distributed kits
Reason for Recall
Kit labeled with the incorrect expiration date.
Firm 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.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.