Z-0982-2019 Class II Terminated
FDA device recall Z-0982-2019 was initiated by Microbiologics Inc on January 31, 2019 and is designated Class II. Reason for recall: Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months. The recall status is terminated (terminated June 9, 2020). Affected quantity: 704 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2019
- Initiation Date
- January 31, 2019
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 704 units
Product Description
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Reason for Recall
Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
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.
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)