30 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
FDA Recall
Terminated
·Lifescan Inc·Product code CGA·November 17, 2003
Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
FDA Recall
Terminated
·Lifescan Inc·Product code CGA·September 9, 2005
LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·November 21, 2003
LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·December 18, 2007
OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·February 24, 2010
LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·September 29, 2006
OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·February 24, 2010
LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
FDA Recall
Terminated
·Lifescan Inc·Product code CGA·September 29, 2006
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Distributed by : LifeScan, Inc. Milpitas, CA 95035 for: LifeScan Europe Division of Cilag GmBH International 6300 Zug Switzerland Meter made in China. Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood.
FDA Recall
Terminated
·Lifescan Inc·Product code LFR·February 21, 2012
OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels
FDA Recall
Terminated
·Lifescan Inc·Product code F·May 27, 2011
OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·November 25, 2008
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·September 19, 2008
One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·January 7, 2010
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ Verio IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ Verio IQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
FDA Enforcement
Class I
·Terminated·Lifescan Inc·April 24, 2013
LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
FDA Enforcement
Class II
·Terminated·Lifescan Inc·April 24, 2013
LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
FDA Enforcement
Class II
·Terminated·Lifescan Inc·April 24, 2013
LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·June 9, 2005
LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
FDA Recall
Terminated
·Lifescan Inc·Product code JJX·February 25, 2013
LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
FDA Recall
Terminated
·Lifescan Inc·Product code JJX·February 25, 2013
OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
FDA Recall
Terminated
·Lifescan Inc·Product code CGA·January 13, 2003