FDA Medical Device Recalls (openFDA)
Remel, Inc.: Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
- Recall number
- Z-0273-04
- Recalling firm
- Remel, Inc.
- Product
- Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
- Status
- Terminated
- Initiated
- 2003-11-03
- Posted
- 2003-12-25
- Terminated
- 2004-01-13
- Reason
- Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area
- Root cause
- Other
- Action
- Letters dated 10/29/03 were issued via regular mail on 11/3/03 requesting the customer to discard remaining inventory of the lot.
- Quantity
- 25 boxes
- Distribution
- Distribution was made to medical facilities, laboratories, and military facilities located in NY, MN, PA, VA, MI, NM, RI, IN, MA, WI, CT, OH, and NC.
- Lot, serial or model codes
- Lot #001453, Exp. 2013-04-03
- 510(k) numbers
- ["K890718"]
- PMA numbers
- not on file
- Product code
- LJG
- 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