Recall Z-0062-04 ยท LLH Reagents, Clostridium Difficile Toxin
Meridian Bioscience Inc
Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
| Date | Oct 24, 2003 (initiated Sep 23, 2003) |
| Status | Terminated |
| Reason | The kits were packaged with incorrect dispensing pipettes. |
| Root cause | Other |
| Action | The firm notified their affected consignees by letter on 9/23/2003. |
| Quantity | 2030 kits |
| Distribution | The kits were shipped to consignees located nationwide, and into New Zealand, Haiti, Belgium, Italy, Brazil, Australia, Canada, and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993914 | PREMIER TOXINS A&B, MODEL 616096 Meridian Diagnostics, Inc., Dec 10, 1999 |