Recall Z-0562-06 ยท NBW System, Test, Blood Glucose, Over The Counter
Becton Dickinson & Company
Paradigm Link -- Blood Glucose Monitor.
| Date | Feb 25, 2006 (initiated Jan 5, 2006) |
| Status | Terminated |
| Reason | BD 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 cause | Other |
| Action | Recall 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 |
| Quantity | 227,240 units |
| Distribution | The 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 record | Open on fda.gov |
510(k) clearances named in this recall
| K041478 | BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR Becton Dickinson, Oct 28, 2004 |