PREMIER EHEC and PREMIER EHEC Bulk.
FDA Recall Z-1033-2017 · Posted 2017-01-17
Recalling FirmMeridian Bioscience Inc
Recall StatusTerminated
Product CodeGNA
Date Initiated2016-11-08
Date Terminated2017-08-16
Product Quantity4,747 EHEC + 180 EHEC Bulk
Reason for Recall
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Firm Action
On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.