Z-2203-2016 Class III Terminated
FDA device recall Z-2203-2016 was initiated by Roche Molecular Systems, Inc. on May 17, 2016 and is designated Class III. Reason for recall: Kit labeled with the incorrect expiration date. The recall status is terminated (terminated February 1, 2017). Affected quantity: 194 distributed kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- February 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 194 distributed kits
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.
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.
Code Information
Lot Numbers: 51222E, 60121H, 60201D, and 60229F