FDA Medical Device Recalls (openFDA)
Remel, Inc.: Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
- Recall number
- Z-0621-2007
- Recalling firm
- Remel, Inc.
- Product
- Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
- Status
- Terminated
- Initiated
- 2007-02-21
- Posted
- 2007-03-14
- Terminated
- 2008-03-06
- Reason
- False negative results for sorbitol fermenting bacteria such as E. Coli 0157.
- Root cause
- Other
- Action
- Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided.
- Quantity
- 694/10-pack boxes
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 506069, Exp. 2007/03/20
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSI
- 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