BD Facsduet™ Sample Preparation Systems

Issue

Through a customer complaint investigation, BD identified a specimen volume bias issue with the BD Facsduet™ sample preparation system when using software version 1.4.1. When the multidispense feature is enabled in the BD Facsduet™ sample preparation system software, and the user is preparing a two-tube assay, the specimen volume dispensed into the first tube will be at least 3% higher than the specimen volume dispensed into the second tube. For assays, where absolute counts are calculated using BD Trucount™ tubes, an increase in the volume may result in higher-than-expected absolute counts in the first tube compared to the second tube. This issue will be observed when preparing the following assays on the BD Facsduet™ sample preparation system: 1. BD Multitest™ IMK kit with BD Trucount™ tubes. note: if using the BD Multitest™ IMK kit with BD Trucount™ tubes, a QC message will appear on your report if the bias is outside the acceptable range per assay requirements. 2. BD Multitest™ 6-color TBNK with BD Trucount™ tubes only if consecutive replicates of two are run. 3. for all other quantitative assays utilizing BD Trucount™ tubes in consecutive replicates of two, please follow your institution's procedures to determine if a review of reported results is necessary. This issue does not affect assays that are determining percent positive, semi quantitative information. Recall start date: August 12, 2024

What you should do

• Contact the manufacturer if you require additional information.