ClearanceBrief
Recall Z-0561-06 ยท NBW System, Test, Blood Glucose, Over The Counter

Becton Dickinson & Company

BD Latitude (DMS) -- Blood Glucose Monitor.

DateFeb 25, 2006 (initiated Jan 5, 2006)
StatusTerminated
ReasonBD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
Root causeOther
ActionRecall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006
Quantity61,716 units
DistributionThe firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include locations in Canada and Germany. There is one VA account.
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