—#28784

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.

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K022580, K022581
Affected lot / code info: Catalog # 322002 (fifty count packaging) Lot Number: 2064256. Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256, 2064273, 2071280.

Why it was recalled

Test Strips may not be meeting specifications at the lower range of glucose values.

Root cause (FDA determination)

Other

Action the firm took

On July 23, Becton Dickinson Canada sent out a recall notification to their Canadian customers to recall the product and return to BD Canada.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Drive, Franklin Lakes, New Jersey 07417

Distribution

Distribution pattern: Product was distributed to the Becton Dickinson Canada, Inc.,

Timeline

Recall initiated: 2003-07-23
Posted by FDA: 2003-09-11
Terminated: 2004-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28784. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.