Product Wiki · Recalls · Health Canada — Medical Devices

Access AMH QC Kit (2016-06-21) — recall 55170

Health Canada — Medical Devices · Canada · 2016-07-07 · 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
55170
Date of alert
2016-07-07
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Beckman Coulter determined that the quality control (QC) value card lists incorrect standard deviation (SD) values for the access AMH QC kit lot 689202.the QC value cards for this lot list the following standard deviation values: QC1 as 0.02, QC2 as 0.11 and QC3 as 0.65. The correct standard deviation values are as follows: QC1 is 0.15, QC2 is 0.76 and QC3 is 2.30.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/access-amh-qc-kit-2016-06-21

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.