Recall Z-2203-2016 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Roche Molecular Systems, Inc.
cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
| Date | Jul 13, 2016 (initiated May 17, 2016) |
| Status | Terminated |
| Reason | Kit labeled with the incorrect expiration date. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER Iquum, Inc., Aug 4, 2011 |