Recall Z-2203-2016
Roche Molecular Systems, Inc. · initiated May 17, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
Codes / lots: Lot Numbers: 51222E, 60121H, 60201D, and 60229F
Reason for recall
Kit labeled with the incorrect expiration date.
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-2203-2016
- Initiated
- May 17, 2016
- Posted by FDA
- July 13, 2016
- Terminated
- February 1, 2017
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- 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.
- Recalling firm
- Roche Molecular Systems, Inc., S Branchburg, NJ