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BD Facsduet™ Sample Preparation Systems — recall 75970

Health Canada — Medical Devices · Canada · 2024-08-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75970
Date of alert
2024-08-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bd-facsduettm-sample-preparati

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