FDA Medical Device Recalls (openFDA)
Medtox Diagnostics Inc: MEDTOXscan Reader
- Recall number
- Z-2202-2008
- Recalling firm
- Medtox Diagnostics Inc
- Product
- MEDTOXscan Reader
- Status
- Terminated
- Initiated
- 2008-02-08
- Posted
- 2008-09-26
- Terminated
- 2012-05-08
- Reason
- Reader was marketed without a 510(k).
- Root cause
- Other
- Action
- Consignees were notified by telephone starting 02/08/2008. They were being read the following script.: This is (company representative) calling regarding the MEDTOXscan Reader , Serial Number #######, that we sent to you on (date). Based on recent discussions with the FDA it has been determined that the reader should have had FDA clearance prior to MEDTOX marketing the reader. Since the MEDTOXscan Reader was marketed without 510(k) clearance it is considered mis-branded. MEDTOX is voluntarily recalling all readers until we receive this clearance. The PROFILE III ER devices sold for use with the readers are appropriately cleared by the FDA, and can be read visually, independent of the reader and therefore are not affected by the recall. Please discontinue using the reader immediately. We will send you shipping materials and instructions on how to return the reader to MEDTOX. You will receive these materials within the next 7 days and we request that you return the reader to MEDTOX within 5 days. Your assistance is appreciated and necessary. The Food and Drug Administration is aware of this recall.
- Quantity
- 391 Readers
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Product number 833062
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DKZ
- Firm FEI
- 1050155
- Firm city
- Burlington
- Firm state
- NC
- 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