Abbott Laboratories of Abbott Park, Illinois just issued a recall for one lot of its <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Abbott Prism HIV O Plus test, said the U.S. Food and Drug Administration (FDA). Lot Number 87334M500â€¨and List Number 03L68-68 are involved in this recall.
Abbott has seen an increase in customer complaints for calibration failures when its PRISM-HIV-1 Group O Positive Assay Control (2) (Symbol: OPC) is out of specification high.
When the OPC does not meet specifications, the PRISM channel is shut down and no results are reported. The calibration report will indicate â€œHRâ€ for the control that is out of specification high. Error Code 02-209 (Data Reduction detected an Assay Control failure) is reported for samples that had been scheduled.
Customers who have an alternate lot of Abbott Prism HIV O Plus are asked to discontinue use of lot 87334M500 and discard remaining inventory. Customers with no alternate lot of Abbott PRISM HIV O Plus are asked to continue use of lot 87334M500 until the replacement kits arrive. â€¨
Abbott spokesman Don Braakman told the Wall Street Journal that “certain calibration controls were found to be out of specification.”
Also, according to Braakman, no reports of tests to blood donations, blood, or the blood product supply have been received, to date, said the Wall Street Journal. Braakman said that in addition to advising the FDA last week, Abbott also advised its customers at that time and has replaced the lot, wrote the Journal.
The Abbott Prism HIV O Plus was approved about one year ago by the FDA, according to the Journal. The product, a medical screening device is used by laboratory professionals for determining the presence of antibodies for the two virusesâ€”HIV-1 and HIV-2â€”that cause AIDS, said the Journal. The device also helps in diagnosing HIV infection and can screen for hepatitis, as well as other infections, added the Journal.
The screening device has been described by Abbott as the â€œfirst fully automated blood screening test for HIV-1/HIV-2,â€ wrote the Journal and runs about 160 samples hourly.