FDA Medical Device Recalls (openFDA)
Meretek Diagnostics, Inc.: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
- Recall number
- Z-0003-2008
- Recalling firm
- Meretek Diagnostics, Inc.
- Product
- BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
- Status
- Terminated
- Initiated
- 2007-05-02
- Posted
- 2007-10-04
- Terminated
- 2007-11-26
- Reason
- Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
- Root cause
- Labeling False and Misleading
- Action
- Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.
- Quantity
- 92 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Version 1.3.5 - January 1, '03
- 510(k) numbers
- ["K014225"]
- PMA numbers
- not on file
- Product code
- MSQ
- Firm FEI
- 3000210499
- Firm city
- Lafayette
- Firm state
- CO
- 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