Device product
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Z-0982-2019
Product summary
- Event
- Event 82077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 704 units
- Official record key
device-enforcement:Z-0982-2019
Official wording
Reason: Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
Code information: Catalog Number 8199; Lot Number (original expiration date YYYY/MM/DD, new expiration date YYYY/MM/DD): 8199-02 (2019/02/28, 2018/03/31), 8199-03 (2019/02/28, 2018/03/31), 8199-04 (2019/05/31, 2018/06/30), 8199-05 (2019/05/31, 2018/06/30), 8199-06 (2019/10/31, 2018/11/30), 8199-07 (2019/05/31, 2018/06/30), 8199-08 (2019/12/31, 2019/01/31), 8199-09 (2019/05/31, 2018/06/30), 8199-10 (2020/01/31, 2019/02/28), 8199-11 (2020/01/31, 2019/02/28), 8199-12 (2020/01/31, 2019/02/28), 8199-13 (2020/01/31, 2019/02/28), 8199-17 (2020/04/30, 2019/05/31), 8199-18 (2020/05/31, 2019/06/30), 8199-19 (2020/10/31, 2019/11/30)
Distribution pattern: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden, Switzerland, United Kingdom.
Derived failure modes
-
Unknown
Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.