FDA Medical Device Recalls (openFDA)
Meridian Bioscience Inc: Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
- Recall number
- Z-0062-04
- Recalling firm
- Meridian Bioscience Inc
- Product
- Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
- Status
- Terminated
- Initiated
- 2003-09-23
- Posted
- 2003-10-24
- Terminated
- 2004-03-29
- 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.
- Lot, serial or model codes
- Lots 616096.095, -096, and -097. Expiration Date: 23 Jul 03.
- 510(k) numbers
- ["K993914"]
- PMA numbers
- not on file
- Product code
- LLH
- 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