FDA Medical Device Recalls (openFDA)
Meridian Bioscience Inc: Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box.
- Recall number
- Z-0464-03
- Recalling firm
- Meridian Bioscience Inc
- Product
- Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box.
- Status
- Terminated
- Initiated
- 2002-12-26
- Posted
- 2003-01-23
- Terminated
- 2004-03-29
- Reason
- Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
- Root cause
- Other
- Action
- 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.
- Quantity
- 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, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
- Lot, serial or model codes
- Lot #616096.053, Exp Date 23 JUL 03; Lot #616096.055, Exp Date 23 JUL 03; Lot #616096.056, Exp Date 23 JUL 03; Kit Catalog #616096.
- 510(k) numbers
- ["K993914"]
- PMA numbers
- not on file
- Product code
- MCB
- Firm FEI
- 1524213
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28