Product Wiki · Recalls · Health Canada — Medical Devices

ROTEM delta (2018-05-12) — recall 59022

Health Canada — Medical Devices · Canada · 2019-03-15 · Type III

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
59022
Date of alert
2019-03-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A defect in the ROTEM delta marketing brochure ""pocket guide"" was noted with the A10 normal ranges that were inconsistent with ranges used in the submission documents and software version 2.7. The ranges used in submission documents and software v2.7 were based on clinical studies in the US. However, the A10 normal ranges used in the guide were inadvertently taken from the EU studies.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/rotem-delta-2018-05-12

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.