FDA News Digest September 3, 2002 __________________________________________________________________ FDA Approves Watch-Like Device to Monitor Glucose in Diabetic Children FDA has approved the GlucoWatch G2 Biographer for monitoring glucose levels in children and adolescents with diabetes. The device does not replace standard finger stick blood tests, but it is capable of providing up to six painless glucose measurements per hour for 13 hours. The GlucoWatch has been approved for adults since March 2001. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00830.html __________________________________________________________________ Gonorrhea Test Kits Recalled After Being Shown to be Unreliable Abbott Laboratories Inc., is recalling about 1.5 million of its laboratory kits used to diagnose the sexually transmitted disease gonorrhea. The kits, distributed to hospitals and laboratories from Jan. 11 to June 24, 2002, were shown to be unreliable because they may give false negative results. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00832.html __________________________________________________________________ Contaminated Honey Import Scheme Uncovered FDA and the U.S. Customs Service have discovered bulk imports of Chinese honey contaminated with low levels of chloramphenicol, a potentially harmful antibiotic and unapproved food additive. The contaminated honey was discovered during an investigation into a scheme to evade U.S. anti-dumping duties. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00831.html __________________________________________________________________ Foods Center Announces New System for Tracking Adverse Events FDA's Center for Food Safety and Applied Nutrition (CFSAN) is developing a new procedure for tracking and analyzing adverse event reports involving foods, cosmetics and dietary supplements. Called the CFSAN Adverse Events Reporting System (CAERS), the new process will help identify potential public health issues associated with products in the marketplace. Officials expect CAERS to be pilot tested in the coming months and be operational by May 2003. http://www.cfsan.fda.gov/~dms/caersltr.html _________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be September 9. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
