Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1221-03

BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by...

Becton Dickinson & Co / initiated 2003-07-23 / Terminated

Becton Dickinson & Company began a recall of BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454... on . The reason FDA records is "Test Strips may not be meeting specifications at the lower range of glucose values". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1221-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
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.
Product code
NBW System, Test, Blood Glucose, Over The Counter
Reason for recall
Test Strips may not be meeting specifications at the lower range of glucose values.
FDA root cause
Other
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.
Quantity in commerce
754800 strips
Distribution
Product was distributed to the Becton Dickinson Canada, Inc.,
Product codes and lots
Catalog # 322002 (fifty count packaging) Lot Number: 2064256.  Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256, 2064273, 2071280.