CanadaTrinity Biotech Oxalate Reagent Kit, Product Code 591-2, Lot 2500711 is affected; identify it by the product name, code 591-2 and lot number 2500711. It was recalled because reagent performance variability can cause a negative bias and under-recovery of oxalate values, potentially producing falsely low patient results. Users should discontinue use, quarantine affected inventory, follow the recall instructions and contact the manufacturer for more information.
What's being recalled
Companies: Trinity Biotech PLC, IDA Business Park, Bray, Wicklow, Ireland, A98H5C8.
How to identify it
Affected products: Oxalate Reagent Kit; Lot or serial number: 2500711; Model or catalogue number: 591-2
The hazard
Trinity Biotech is recalling Oxalate Reagent B, Product Code 591-2, Lot 2500711 due to performance variability resulting in negative bias and under-recovery of oxalate values, potentially causing falsely low patient results. Users should discontinue use, quarantine affected inventory, and follow recall instructions.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)