Class 2 Device Recall PREMIER EHEC and PREMIER EHEC Bulk

• Date Initiated by Firm: November 08, 2016
• Date Posted: January 17, 2017
• Recall Status: Terminated on August 16, 2017
• Recall Number: Z-1033-2017
• Recall Event ID: 75651
• 510(K)Number: K953362
• Product Classification: Antisera, all types, escherichia coli - Product Code GNA
• Product: PREMIER EHEC and PREMIER EHEC Bulk.
• Code Information: PREMIER EHEC Product Code 608096: Lot # 608096H219, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138 Exp Date 9/30/2017; Lot # 608096H222, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14 Exp Date 1/12/2018; Lot # 608096H224, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.141 Exp Date 1/29/2018; Lot # 608096H225, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.142, Exp Date 2/5/2018 & Lot # 608096H226, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018. PREMIER EHEC Bulk Product Code 608096BU: Lot # 608096H220 Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138, Exp Date 9/30/2017; Lot #, 608096H223, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14, Exp Date 1/12/2018 & Lot # 608096H227, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018.
• FEI Number: 1524213
• Recalling Firm/ Manufacturer: Meridian Bioscience Inc; 3471 River Hills Dr; Cincinnati OH 45244-3023
• For Additional Information Contact: Chris M. Ross; 800-343-3858
• Manufacturer Reason for Recall: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
• FDA Determined Cause: Under Investigation by firm
• Action: On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers.
• Quantity in Commerce: 4,747 EHEC + 180 EHEC Bulk
• Distribution: Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY. Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND.
• 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.

• 510(K) Database: 510(K)s with Product Code = GNA