220 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code NBW·December 22, 2010
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
Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code NBW·June 10, 2009
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
RiteAid Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
FDA Recall
Terminated
·Abbott Laboratories Medisense Products·Product code NBW·June 7, 2005
Liberty Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
FDA Recall
Terminated
·Abbott Laboratories Medisense Products·Product code NBW·June 7, 2005
One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips
FDA Recall
Terminated
·Discount Diabetic Supply·Product code NBW·October 19, 2006
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code NBW·November 18, 2013
ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code NBW·October 25, 2013
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code NBW·March 15, 2016
Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019
PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code NBW·December 2, 2019
PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code NBW·December 2, 2019
One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
FDA Recall
Terminated
·Core Care Technologies, Inc·Product code NBW·October 14, 2006
LifeScan OneTouch SureSoft Lancing Device, single use lancing device.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·October 11, 2005
OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese)
FDA Recall
Terminated
·Medishop USA·Product code NBW·October 17, 2006
Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code NBW·March 1, 2007
ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code NBW·June 7, 2005
OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·March 22, 2007
ReliOn Ultima Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
FDA Recall
Terminated
·Abbott Laboratories Medisense Products·Product code NBW·June 7, 2005