Recall Z-1033-2017 ยท GNA Antisera, All Types, Escherichia Coli
Meridian Bioscience Inc
PREMIER EHEC and PREMIER EHEC Bulk.
| Date | Jan 17, 2017 (initiated Nov 8, 2016) |
| Status | Terminated |
| Reason | Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. |
| Root 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 | 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 ZEAL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953362 | PREMIER EHEC Meridian Diagnostics, Inc., Nov 14, 1995 |