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U.S. Department of Health and Human Services

Class 3 Device Recall Cepheid Xpert C. difficile/Epi Control Panel

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  Class 3 Device Recall Cepheid Xpert C. difficile/Epi Control Panel see related information
Date Initiated by Firm May 16, 2019
Create Date June 18, 2019
Recall Status1 Open3, Classified
Recall Number Z-1838-2019
Recall Event ID 82787
510(K)Number K190463  
Product Classification Assayed external control material for microbiology nucleic acid amplification (NAT) assays - Product Code PMN
Product Cepheid Xpert C. difficile/Epi Control Panel
Code Information UDI: 70845357041370, Lot Number 8200-26
Recalling Firm/
Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact tech support
Manufacturer Reason
for Recall
Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
FDA Determined
Cause 2
Error in labeling
Action The firm initiated the recall by email on 05/20/2019. The notice requested the consignee relabel the product with the correct date and return the completed response form.
Quantity in Commerce 22 units
Distribution NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PMN and Original Applicant = Microbiologics, Inc.