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Bd facsduet™ sample preparation systems
Official notice
27 Aug 2024
Last checked
27 Aug 2024
An official Health Canada notice concerns Bd facsduet™ sample preparation systems. 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 Published 2024-08-27.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75970
Official notice
2024-08-27
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
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Brand: Becton Dickinson And Bd Biosciences, Bd Facsduet™ Sample Preparation.
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Documents, notices & source
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