Urgent Field Safety Notice - HPRA

FIELD SAFETY NOTICE REPLY FORM for Hospital / Centres NxStage System One S Cycler Model NX1000-3 / NX1000-3-A Please complete this form even if you do not have any System One S Cyclers

Internal testing confirmed that when using calibrator barcode labels supplied with VITROS® Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may

REPLY FORM – QIL 152-001 OLYMPUS URGENT FIELD SAFETY NOTICE NEW OPERATING AND REPROCESSING INSTRUCTIONS FOR THE OLYMPUS TJF-160VR DUODENOVIDEOSCOPE [Name & Address of

Reason for Field Safety Corrective Action: There have been reports that the RECLAIM® Taper Sleeve Protector instrument can be difficult to remove from the distal stem both before

--- Urgent Field Safety Notice Commercial name of the affected product: Zenith TX2 TAA Endovascular Graft with Pro- Form Proximal Component FSCA-identifier: FSCA-2014-03-31 Type

Action required: Customers must be given the following advice: • The use of Accutrend BM-Lactate in clinical settings / hospitals: Customers have to stop using all lots of Accutrend

The table shows the bias observed in our investigation across the measuring range*: Observed Bias for Serum Samples using VITROS® Na+ Slides, GENs 7-13 Overall Average Mean Bias

HRB 661090 Urgent Field Safety Notice Field Safety Corrective Action: Affixing warning notice – identification and discarding affected component Trade name: CombiSets® containing