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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00437-1
Product Name/Description IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). An in vitro diagnostic medical device (IVD)

Reference Number: 800-7211
Lot Numbers: 336-15, 343-15 (Exp April 2016)
Lot Numbers: 004-16,006-16,019-16,021-16,182-15 (Exp May 2016)

Reference Number: 800-7702
Lot Numbers: 313-15, 336-15 (Exp April 2016)
Lot Numbers: 004-16 (Exp May 2016)

Reference Number: 800-7211
Lot Number: 309-15 (Exp April 2016)

ARTG Number: 177551
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/04/2016
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue The manufacturer, Iris International has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the IRISpec CA bilirubin control material. The control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until QC passes.
Recall Action Recall for Product Correction
Recall Action Instructions Beckman Coulter is advising users to ensure the directions for handling and storage of the control material as per the IFU are followed to prevent premature degradation of the control material.
Users are advised to discard the bottle if the QC fails and use alternative bottles in the kit. If the problem persists, request a product replacement from Beckman Coulter. This action has been closed-out on 03/02/2017.
Contact Information 1800 060 881 - Beckman Coulter