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

• Date Initiated by Firm: May 16, 2019
• Create Date: June 18, 2019
• Recall Status: Open, 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/ Manufacturer: Microbiologics Inc; 200 Cooper Ave N; Saint Cloud MN 56303-4440
• For Additional Information Contact: tech 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: 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.