Date Initiated by Firm |
July 23, 2003 |
Date Posted |
September 11, 2003 |
Recall Status1 |
Terminated 3 on December 02, 2004 |
Recall Number |
Z-1221-03 |
Recall Event ID |
26927 |
510(K)Number |
K022580 K022581
|
Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
|
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. |
Code Information |
Catalog # 322002 (fifty count packaging) Lot Number: 2064256. Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256, 2064273, 2071280. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Drive Franklin Lakes NJ 07417
|
For Additional Information Contact |
Wayne Kazarian 201-847-6087
|
Manufacturer Reason for Recall |
Test Strips may not be meeting specifications at the lower range of glucose values.
|
FDA Determined Cause 2 |
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., |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = BECTON DICKINSON & CO.
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