ClearanceBrief
Recall Z-0856-2007 ยท NBW System, Test, Blood Glucose, Over The Counter

Abbott Diabetes Care, Inc.

Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.

DateJun 7, 2007 (initiated Mar 5, 2007)
StatusTerminated
ReasonThe front button covers may detach from the meter.
Root causeOther
ActionThe firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.
Quantityapproximately 300 lots
DistributionProduct was distributed worldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K033845PRECISION XCEED DIABETES MONITORING SYSTEM
Abbott Laboratories, Jan 8, 2004
K040814MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
Abbott Laboratories, Apr 15, 2004