Z-1033-2017 Class II Terminated
FDA device recall Z-1033-2017 was initiated by Meridian Bioscience Inc on November 8, 2016 and is designated Class II. Reason for recall: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. The recall status is terminated (terminated August 16, 2017). Affected quantity: 4,747 EHEC + 180 EHEC Bulk.
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- November 8, 2016
- Termination Date
- August 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,747 EHEC + 180 EHEC Bulk
Product Description
PREMIER EHEC and PREMIER EHEC Bulk.
Reason for Recall
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Distribution Pattern
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.
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.