Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
FDA device recall Z-0062-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Meridian Bioscience Inc
- Reason for recall
- The kits were packaged with incorrect dispensing pipettes.
- Action taken
- The firm notified their affected consignees by letter on 9/23/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLH
- Quantity affected
- 2030 kits
- Distribution
- The kits were shipped to consignees located nationwide, and into New Zealand, Haiti, Belgium, Italy, Brazil, Australia, Canada, and Chile.
- Date initiated
- 2003-09-23
- Date posted
- 2003-10-24
- Date terminated
- 2004-03-29
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PREMIER TOXINS A&B, MODEL 616096 (K993914) | Meridian Diagnostics, Inc. | 1999-12-10 |