BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.
FDA Recall Z-1221-03 · Posted 2003-09-11
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeNBW
Date Initiated2003-07-23
Date Terminated2004-12-02
Product Quantity754800 strips
Reason for Recall
Test Strips may not be meeting specifications at the lower range of glucose values.
Firm Action
On July 23, Becton Dickinson Canada sent out a recall notification to their Canadian customers to recall the product and return to BD Canada.
Root Cause
Other
Distribution Pattern
Product was distributed to the Becton Dickinson Canada, Inc.,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.