U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
System, Test, Blood Glucose, Over The Counter - Product Code NBW
원인
Lifescan brand onetouch ultra meter - owner's booklets are missing instructions on how to set the units of measurement (uom)--mg/dl versus mmol/l. this error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dl of glucose is equal to 1 (one) mmol/l.
조치
Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner''s booklet.
The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner''s Booklets between March 31, 2003 and October 3, 2003.
제품 설명
LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; || Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037