Recall of Abbott Prism HIV O Plus

DATE RECALL INITIATED:

September 3, 2010

PRODUCT / LOT NUMBER/

Product: Abbott Prism HIV O Plus

Lot Number: 87334M500
List Number: 03L68-68

MANUFACTURER:

Abbott Laboratories
Abbott Park, Illinois

REASON:

Abbott has seen an increase in customer complaints for calibration failures when PRISM-HIV-1 Group O Positive Assay Control (2) (Symbol: OPC) is out of specification high. When the OPC does not meet specification, the PRISM channel is shutdown and no results are reported. The calibration report will indicate “HR” 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 who do not have an alternate lot of Abbott PRISM HIV O Plus are asked to continue use of lot 87334M500 until the replacement kits arrive.
 

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.