Recall Z-0763-04 ยท NBW System, Test, Blood Glucose, Over The Counter
Becton Dickinson & Company
BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test st
| Date | Jul 20, 2004 (initiated Jan 29, 2004) |
| Status | Terminated |
| Reason | 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing. |
| Root cause | Other |
| Action | Trade and health care professionals were sent recalled letters dated 1/29/2004. |
| Quantity | 15011221 |
| Distribution | The 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 record | Open on fda.gov |
510(k) clearances named in this recall
| K022580 | BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM Becton, Dickinson & CO, Oct 9, 2002 |
| K022581 | BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM Becton, Dickinson & CO, Oct 9, 2002 |
| K030531 | MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER Minimed, Inc., Jun 17, 2003 |