FDA Medical Device Recalls (openFDA)
Remel, Inc: Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS.
- Recall number
- Z-0069-04
- Recalling firm
- Remel, Inc
- Product
- Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS.
- Status
- Terminated
- Initiated
- 2003-10-02
- Posted
- 2003-10-24
- Terminated
- 2004-02-25
- Reason
- Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae
- Root cause
- Other
- Action
- The recalling firm initiated recall via letter dated 10/2/03 issued regular mail requesting the customer destroy remaining inventory of the affected lot numbers.
- Quantity
- 404/10-pks; 67/15-pks; and 33/100-pkg. cases
- Distribution
- Distribution was made nationwide to facilities with medical laboratories, including military and government facilities.
- Lot, serial or model codes
- 10 pack - Lot #384341, Exp. 11/03/2003; 15 pack - Lot #384342, Exp. 11/3/2003; 100/cs - Lot #384343
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTY
- 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