PlainRecalls
FDA Devices Moderate Class II Terminated

PREMIER EHEC and PREMIER EHEC Bulk.

Reported: January 25, 2017 Initiated: November 8, 2016 #Z-1033-2017

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.

Details

Recalling Firm
Meridian Bioscience Inc
Units Affected
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.
Location
Cincinnati, OH

Frequently Asked Questions

What product was recalled?
PREMIER EHEC and PREMIER EHEC Bulk.. Recalled by Meridian Bioscience Inc. Units affected: 4,747 EHEC + 180 EHEC Bulk.
Why was this product recalled?
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1033-2017.