Product Wiki · Recalls · Health Canada — Medical Devices

VITROS XT 7600 Integrated & 3400 Chemistry System (2020-07-24) — recall 61544

Health Canada — Medical Devices · Canada · 2020-08-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61544
Date of alert
2020-08-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: During internal testing, ortho identified that slot 18 of some cm rotors of the VITROS XT 7600 and XT 3400 systems were not machined adequately, leaving a rough surface that may contribute to the misalignment of a slide at the time of the reflectometer reading. When a microslide is improperly positioned within slot 18 of the cm rotors, a condition code may not post. If an undetected microslide position error occurs, an erroneous test result may be generated.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-xt-7600-integrated-3400

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