BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics,
FDA device recall Z-0003-2008 · posted 2007-10-04 · Terminated
Recall details
- Recalling firm
- Meretek Diagnostics, Inc.
- Reason for recall
- Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- MSQ
- Quantity affected
- 92 units
- Distribution
- Nationwide.
- Date initiated
- 2007-05-02
- Date posted
- 2007-10-04
- Date terminated
- 2007-11-26
- Location
- Lafayette, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BREATHTEK - UBIT UBT FOR H. PYLORI (K014225) | Meretek Diagnostics, Inc. | 2002-01-17 |