Recall Z-1033-2017
Meridian Bioscience Inc · initiated November 8, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PREMIER EHEC and PREMIER EHEC Bulk.
Codes / lots: 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.
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 taken
On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers.
Details
- Recall number
- Z-1033-2017
- Initiated
- November 8, 2016
- Posted by FDA
- January 17, 2017
- Terminated
- August 16, 2017
- Product code
- GNA – Antisera, All Types, Escherichia Coli
- Quantity
- 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.
- Recalling firm
- Meridian Bioscience Inc, Cincinnati, OH