Recall Z-0003-2008 ยท MSQ Test, Urea (Breath Or Blood)
Meretek Diagnostics, Inc.
BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
| Date | Oct 4, 2007 (initiated May 2, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI Meretek Diagnostics, Inc., Jan 17, 2002 |