Health Canada — Medical Devices · Canada · 2025-04-28 · 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 identified an issue with REMISOL Advance when receiving a sample order from the Laboratory Information System (LIS) if the patient's Date of Birth (DOB) is not entered or is unknown: If the LIS sends 01/01/1900 as the DOB, REMISOL Advance using the ASTM host driver incorrectly interprets the age as 0 days. If the LIS sends an empty DOB, REMISOL Advance using the HL7 host driver incorrectly interprets the age as 0 days. Recall start date: April 7, 2025
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.