Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0272-06

LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter

Lifescan, Inc. / initiated 2005-10-10 / Terminated

Lifescan Inc began a recall of LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter on . The reason FDA records is "Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0272-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Lifescan, Inc.
Product
LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter
Product code
NBW System, Test, Blood Glucose, Over The Counter
Reason for recall
Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
FDA root cause
Other
Action
A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit.
Quantity in commerce
2843 kits
Distribution
Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution
Product codes and lots
Listing Number B026094, Code 90273 Kaban, all demo kits shipped between 04/08/2005 and 08/23/2005