PREMIER EHEC and PREMIER EHEC Bulk.
FDA device recall Z-1033-2017 · posted 2017-01-17 · Terminated
Recall details
- Recalling firm
- Meridian Bioscience Inc
- Reason for recall
- Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
- Action taken
- On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GNA
- Quantity 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. Pr
- Date initiated
- 2016-11-08
- Date posted
- 2017-01-17
- Date terminated
- 2017-08-16
- Location
- Cincinnati, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PREMIER EHEC (K953362) | Meridian Diagnostics, Inc. | 1995-11-14 |