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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01295-1
Product Name/Description Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. An in vitro diagnostic medical device (IVD)

Catalogue Number: 1955700
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 24/12/2012
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue There is a risk of false negative results being reported in urine samples; the concentration of adrenaline/epinephrine may decrease when analysis time is more than 8 hours. This occurs when the samples are subsequently adjusted to pH 5 to 7 as described in the instructions for use for very acidic samples or samples with low 24-volumes
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor is providing an update to the Instructions for Use (IFU).
Contact Information 1800 224 354 - Bio-Rad Laboratories