Product Wiki · Recalls · Health Canada — Medical Devices

UniCel DxH 600, 800, and 900 Coulter Cellular Analysis System… — recall 58271

Health Canada — Medical Devices · Canada · 2019-06-04 · Type I

As described by Health Canada — Medical Devices: UniCel DxH 600, 800, and 900 Coulter Cellular Analysis System (2018-08-01)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
58271
Date of alert
2019-06-04
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Beckman Coulter has confirmed complaints of sporadic erroneously elevated platelet results without flags or system messages. Other parameters are not affected by this issue. The platelet parameter may be erroneously elevated without flags or system messages. Erroneously elevated results could be reported out of the laboratory.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxh-600-800-and-900-cou

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