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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 Panelsee related information
Date Initiated by FirmMay 16, 2019
Create DateJune 18, 2019
Recall Status1 Open3, Classified
Recall NumberZ-1838-2019
Recall Event ID 82787
510(K)NumberK190463 
Product Classification Assayed external control material for microbiology nucleic acid amplification (NAT) assays - Product Code PMN
ProductCepheid Xpert C. difficile/Epi Control Panel
Code Information UDI: 70845357041370, Lot Number 8200-26
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contacttech support
320-229-7064
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
ActionThe 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 Commerce22 units
DistributionNY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = PMN
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