ClearanceBrief
Recall Z-1221-03 ยท NBW System, Test, Blood Glucose, Over The Counter

Becton Dickinson & Company

BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.

DateSep 11, 2003 (initiated Jul 23, 2003)
StatusTerminated
ReasonTest Strips may not be meeting specifications at the lower range of glucose values.
Root causeOther
ActionOn July 23, Becton Dickinson Canada sent out a recall notification to their Canadian customers to recall the product and return to BD Canada.
Quantity754800 strips
DistributionProduct was distributed to the Becton Dickinson Canada, Inc.,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022580BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
Becton, Dickinson & CO, Oct 9, 2002
K022581BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
Becton, Dickinson & CO, Oct 9, 2002