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 strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.
FDA Recall Z-0763-04 · Posted 2004-07-20
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeNBW
Date Initiated2004-01-29
Date Terminated2004-10-29
Product Quantity15011221
Reason for Recall
39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
Firm Action
Trade and health care professionals were sent recalled letters dated 1/29/2004.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K030531MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METERMinimed, Inc. · 2003-06-17K022580BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEMBecton, Dickinson & CO · 2002-10-09K022581BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEMBecton, Dickinson & CO · 2002-10-09
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.