Product Wiki · Recalls · Health Canada — Medical Devices

VITROS XT 7600 Integrated System (2019-03-10) — recall 59409

Health Canada — Medical Devices · Canada · 2019-03-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59409
Date of alert
2019-03-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Ortho Clinical Diagnostics identified this issue during internal testing. When the unreported sample dispense error occurs, either a smaller volume of sample or no sample is dispensed on a slide, and the associated condition code is not reported to the operator via the Status console or Condition Review screen. Samples with increased viscosity are more susceptible to these sample dispense errors. If an unreported sample dispense error occurs, the expected condition code (TE6-47E or TE6-47J) is not reported, and the test result for the sample is not suppressed. Other algorithms that are designed to detect conditions involving smaller than expected volumes due to bubbles, clots or pressure leaks are functioning as expected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-xt-7600-integrated-syst

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