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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00559-1
Product Name/Description	SYNCHRON Systems Lactate (LACT). An in vitro diagnostic medical device (IVD). Reference number: A95550 Lot number: M210077 Expiration date: 2013-10-31
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	3/06/2013
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has confirmed customer reports of the affected lot failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions.
Recall Action	Recall
Recall Action Instructions	Beckman Coulter is requesting end users to discontinue use of the affected lot. Re-assessment of past results is not required as the LACT results produced after acceptable QC recoveries on each reagent cartridge are accurate.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre