FDA: Abbott Recalls Some HIV Blood Screening Tests
September 13, 2010
The Food and Drug Administration said Thursday that Abbott Laboratories has recalled some HIV blood tests after customers complained of "calibration failures." Approved by FDA almost a year ago, the Prism HIV O Plus test is used by laboratory professionals. Abbott says it is the first fully automated blood screening test for HIV-1 and HIV-2. Abbott spokesperson Don Braakman said the company knows of no effect on blood donations or the supply of blood products. The company notified its customers and FDA of the problem last week and already has replaced the lot in question, he added. The recalled tests carry lot number 87334M500. FDA said customers who have an alternate supply of the product should stop using the recalled lot and discard it. Customers with no alternate supply should continue using the recalled lot until replacement tests arrive. For more information, visit www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm225303.htm.
Dow Jones Newswires
09.09.2010; Peter Loftus
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.
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