cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
This recall has been terminated (originally issued July 13, 2016).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- May 17, 2016
- Posted
- July 13, 2016
- Terminated
- February 1, 2017
- Recall Number
- Z-2203-2016
- Quantity
- 194 distributed kits
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Kit labeled with the incorrect expiration date.
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.
Lot / Code Info
Lot Numbers: 51222E, 60121H, 60201D, and 60229F
Root 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.