Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box.
FDA device recall Z-0464-03 · posted 2003-01-23 · Terminated
Recall details
- Recalling firm
- Meridian Bioscience Inc
- Reason for recall
- Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
- Action taken
- The firm mailed notices to their affected customers on 12/26/2002. The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps. If properly sealed, the use of the microwells may be continued. Test wells in pouches with defective seals are to be quarantined and destroyed. The customers are asked to report back to the firm. All test microwell plates in defective pouches will be replaced by the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCB
- Quantity affected
- 1,409 kits
- Distribution
- The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Braz
- Date initiated
- 2002-12-26
- Date posted
- 2003-01-23
- 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 |