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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: 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.

Recall number
Z-1221-03
Recalling firm
Becton Dickinson & Company
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.
Status
Terminated
Initiated
2003-07-23
Posted
2003-09-11
Terminated
2004-12-02
Reason
Test Strips may not be meeting specifications at the lower range of glucose values.
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
754800 strips
Distribution
Product was distributed to the Becton Dickinson Canada, Inc.,
Lot, serial or model codes
Catalog # 322002 (fifty count packaging) Lot Number: 2064256.  Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256, 2064273, 2071280.
510(k) numbers
["K022580","K022581"]
PMA numbers
not on file
Product code
NBW
Firm FEI
2243072
Firm city
Franklin Lakes
Firm state
NJ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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