ClearanceBrief
Recall Z-0764-04 ยท NBW System, Test, Blood Glucose, Over The Counter

Becton Dickinson & Company

The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. US Market BD Blood Glucose Monitoring System kit catalog Numbers: 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); 322050 (BD Latitude Diabetes Management Syst

DateJul 20, 2004 (initiated Jan 29, 2004)
StatusTerminated
Reason39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
Root causeOther
ActionTrade and health care professionals were sent recalled letters dated 1/29/2004.
Quantity207092
DistributionThe product was shipped nationwide to 28 Wholesalers, 15 retail pharmacies and pharmacy chains, 18 managed markets/Mail order facilities, and 616 health care professionals. There are 29 Canadian consignees.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.