Trinity Biotech Recalls Oxalate Reagent B (Lot 2500711) Due to Performance Variability

Trinity Biotech has issued a recall of its Oxalate Reagent B, identified by Product Code 591-2 and Lot number 2500711. The recall is prompted by observed performance variability that introduces a negative bias and under‑recovery of oxalate values in testing. This variability can lead to falsely low oxalate results for patients, potentially affecting clinical decisions. Health Canada advises users to immediately discontinue use of the affected reagent, quarantine any remaining inventory, and follow the specific recall instructions provided by Trinity Biotech. Laboratories and healthcare facilities should verify that the recalled lot is not in use and replace it with an approved alternative. The recall underscores the importance of rigorous quality control in clinical chemistry reagents to ensure accurate patient testing outcomes.