Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
- Company
- Microbiologics Inc
- Recall Initiated
- January 31, 2019
- Posted
- March 7, 2019
- Terminated
- June 9, 2020
- Recall Number
- Z-0982-2019
- Quantity
- 704 units
- Firm Location
- Saint Cloud, MN
Reason for Recall
Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
Distribution
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.
Lot / Code Info
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)
Root Cause
Error in labeling
Action Taken
On about 01/31/2019, Microbiologics notified customers via an "Important Medical Device Correction" letter, sent through email. The letter notified customers of the change in expiration date, instructed customers to update their records with the provided new expiration date, to not use the product after the expiration date, and to complete and return the "MEDICAL DEVICE CORRECTION CUSTOMER RESPONSE FORM." For questions, contact Technical Support at 1-320-229-7064 or techsupport@microbiologics.com.