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U.S. Department of Health and Human Services

Class 2 Device Recall Cepheid Respiratory Control Panel

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  Class 2 Device Recall Cepheid Respiratory Control Panel see related information
Date Initiated by Firm January 31, 2019
Date Posted March 07, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-0982-2019
Recall Event ID 82077
Product Classification Assayed external control material for microbiology nucleic acid amplification (NAT) assays - Product Code PMN
Product Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
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) 
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact
320-229-7064
Manufacturer Reason
for Recall		 Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 704 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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