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Murex SUDS HIV-1 (Rapid EIA) Dear Healthcare Professional Letter Oct 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Abbott Diagnostics Division, Abbott Laboratories Inc. Contact the company for a copy of any referenced enclosures.


October 17, 2000

Dear SUDS HIV-1 Customer:

Currently, the Abbott Murex SUDS HIV-1 test is experiencing manufacturing problems related to the failure to meet certain panel and negative control specifications. As a result, Abbott has exhausted its supply of the HIV SUDS product. This letter is intended to provide you with some information concerning this problem, what we are doing to resolve it, and to inform you as to when you may expect shipments to resume.

Historically, the Abbott Murex SUDS HIV-1 master kit production has had a consistent acceptance rate; however, recent manufacturing problems have resulted in our halting production in order to perform an appropriate investigation. The investigation is ongoing.

As part of this investigation, all product components are being evaluated as a potential cause for this problem. Tracking and trending is also being performed to identify variability in the process. Abbott is aggressively working to determine the cause of the problem and complete its investigation. While the actual date of re-starting production cannot be determined at this time, Abbott Murex has added additional resources to assist in resolving the issue. We hope to be able to resume production within the next 30 days.

In the meantime, other licensed HIV EIA tests may be used, a licensed immunofluorescence, IFA, may be used or samples may be sent to a reference laboratory that performs HIV testing. A full listing of all approved HIV screening tests may be found at http://www.fda.gov/cber/products/testkits.htm. If you do not know of a laboratory in your area that performs HIV testing your Abbott representative can assist you.

Abbott Diagnostics regrets any inconvenience this situation has caused your laboratory and we would like to thank you for your patience during the current interruption in the supply of your HIV-1 SUDS product.

Again, please accept our apology for the inconvenience that we have caused your facility during this product shortage.

Sincerely,

Gene Cartwright, Ph.D.
Vice President, U.S. Marketing
Abbott Diagnostics


Abbott Diagnostics Division
Abbott Laboratories Inc.
100 Abbott Park Road
Abbott Park, Illinois 60064-6092