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
| 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 | 207092 |
| 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
This recall record lists no 510(k) number.