FDA Medical Device Recalls (openFDA)
Remel, Inc.: Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.
- Recall number
- Z-0024-05
- Recalling firm
- Remel, Inc.
- Product
- Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.
- Status
- Terminated
- Initiated
- 2004-09-27
- Posted
- 2004-10-20
- Terminated
- 2006-04-25
- Reason
- The product does not perform as intended with some quality control organisms (Haemophilus influenzae)
- Root cause
- Other
- Action
- The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.
- Quantity
- 4,620 units (308 packages)
- Distribution
- Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK.
- Lot, serial or model codes
- Lot #435902, Exp. 2004-11-04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KZI
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- 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