Official recall record
Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
UIBC OSR61205 is not meeting interference claims for haemoglobin interference serum application. As per product ifus the claim is less than 10% up to 2g/l haemoglobin. While the high pool is meeting the claim, the low pool is failing the hemolysate interference specifications with results of -43.63% or -8.95 μmol/l. Recall start date: July 1, 2025
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.