Health Canada — Medical Devices · Canada · 2024-07-26 · Type II
🏛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 →
Reported risk: Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB glucose control failure, resulting in false positive results when used in conjunction with iChemVELOCITY Urine Chemistry Strips PNS 800-7204 and 800- 7212. If a QC run fails, the system will not allow the operator to run patient samples. The QC run should be repeated and pass successfully before running patient samples. Recall start date: July 16, 2024
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.
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.