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 company will withdrawn certain products from the market for a period of no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.
>
>
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