 |
 |
Dear colleagues, A (rather ambiguous) News Release on the Abbott Website may offer some reassurance to those concerned about Abbott test availability. http://www.abbott.com/news/1999news/pr110299.htm "The products on the market continue to provide accurate results. Abbott will not need to recall any diagnostic products as a result of this decree."...................... "The decree allows for the continued manufacture and distribution of medically necessary diagnostic products made in Lake County, Ill., such as assays for hepatitis, retrovirus, cardiovascular disease, cancer, thyroid disorders, fertility, drug monitoring, and congenital and respiratory conditions. However, Abbott is prohibited from manufacturing or distributing certain diagnostic products until Abbott ensures the processes in its Lake County, Ill., diagnostics manufacturing operations conform with the current Quality System Regulation."................. "This decree allows us to resolve these issues comprehensively and systematically without disruption to patient care world-wide," said Miles D. White, chairman and chief executive officer. "We will work closely and cooperatively with the FDA to ensure our Lake County, Ill., diagnostic manufacturing operations are in full and complete conformance as rapidly as possible." I suggest that we give our Abbott Sales Representatives a few days to sort out what is happening and find out what effect this agreement will have on supplies. Regards Graham Ellis Dr. Graham Ellis Dept. of Clinical Biochemistry St. John's Hospital Livingston West Lothian Scotland EH54 6PP [log in to unmask] Phone: (from UK) 01506 422756 Ext: 3343 Fax (from UK) 01506 460301 (from Canada): 011 44 1506 422756 Ext: 3343 Fax (from Canada) 011 44 1506 460301 > -----Original Message----- > From: Garg, Uttam [SMTP:[log in to unmask]] > Sent: 03 November 1999 14:41 > To: [log in to unmask] > Subject: FW: ASCP Clinical Chemistry Update > > I received the following news from ASCP Clin Chem Update. > > Uttam Garg, PhD, DABCC > Associate Professor > Director of Clinical Chem & Toxicology and > Co-Director of Biochem Genetics Labs > Children's Mercy Hospital > Kansas City, MO 64108 > Phone: 816-234-3803 > Fax: 816-234-3794 > > > > > -----Original Message----- > > From: Robin Stombler [SMTP:[log in to unmask]] > > Sent: Wednesday, November 03, 1999 6:58 AM > > To: ASCP Chemistry Listserver > > Subject: ASCP Clinical Chemistry Update > > > > For your information - > > > > On November 2, 1999, Abbott Laboratories entered into a consent > agreement > > with the Food and Drug Administration to address agency concerns > that the > > company is out of compliance with government regulations at a plant > that > > makes chemical kits used in the company's medical diagnostic > equipment. > > > > The consent agreement establishes a validation schedule whereby the > > company will withdrawn certain products from the market for a period > of no > > more than 12 months. Abbott maintains that its products remain safe > and > > efficacious, but agreed to withdraw these products in order to > validate > > and remove any uncertainty with its compliance with government > > regulations. > > The affected products are: > > > > B12 (all instruments); > > Folate (all instruments); > > Ferritin (all instruments); > > Testosterone (Architect); > > ERICA/PgRICA (diagnostic reagent); > > HIV1 (EIA); > > Chagas (EIA); > > Chlamydiazyme (EIA); > > HIV AB P24 (EIA); > > HBe (EIA); > > HBV DNA (EIA); > > ER/PGR (EIA); > > Rotozyme (EIA); > > Chlamydia (IMx); > > Insulin (IMx); > > Surface Antigen (IMx); > > CA 19-9 (IMx); > > Entire TestPack Family (Rapid Testing); > > AUSRIA (RIA); > > Corab (RIA); > > Ethosuximide (TDx/TDxFLx); > > Lidocaine (TDx/TDxFLx); > > Disopyrimide (TDx/TDxFLx); > > CRP (TDx/TDxFLx); > > Netilmicin (TDx/TDxFLx); > > Primidone (TDx/TDxFLx); > > Cortisol (TDx/TDxFLx); > > All Vision Tests except T4, Glycated Hemoglobin, Phenytoin and > > Theophylline (Vision). > > > > Abbott has informed ASCP that while these products are off the > market, the > > company will help ensure continuity of supply until the products may > > reenter the marketplace. If you have questions, a special Abbott > customer > > service number is available to you at 1-877-738-6035. > > > > > > If you have other questions, please contact the ASCP Washington > Office at > > (202) 347-4450. > > > > %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%