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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD Latitude (DMS) -- Blood Glucose Monitor.

Recall number
Z-0561-06
Recalling firm
Becton Dickinson & Company
Product
BD Latitude (DMS) -- Blood Glucose Monitor.
Status
Terminated
Initiated
2006-01-05
Posted
2006-02-25
Terminated
2006-09-05
Reason
BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
Root cause
Other
Action
Recall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006
Quantity
61,716 units
Distribution
The firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include locations in Canada and Germany. There is one VA account.
Lot, serial or model codes
All lots under the following Catalog numbers:  322050; 322000; 322015; 322067.
510(k) numbers
["K022580"]
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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