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Class 3 Device Recall Cepheid Xpert C. difficile/Epi Control Panel |
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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
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Product Classification |
Assayed external control material for microbiology nucleic acid amplification (NAT) assays - Product Code PMN
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Product |
Cepheid 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
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For Additional Information Contact |
tech support 320-229-7064
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Manufacturer Reason for Recall |
Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
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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
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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.
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510(K) Database |
510(K)s with Product Code = PMN and Original Applicant = Microbiologics, Inc.
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