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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00151-1
Product Name/Description	COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical device (IVD) Reference Number: 7546978 Lot Number: 108912K Expiry Date: 11/12/2016 ARTG Number: 223049
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	8/02/2016
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has received an increased number of customer complaints related to the inability to scan or manually enter the ReticPrep barcode label. The ReticPrep Barcode Label number 2 contains characters that are not recognised by the software ("+$$" instead of "22"), and due to this issue the system will not generate results. The reported issue may lead to a delay in test results reporting. However, it is unlikely to cause adverse health consequences.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is advising users to follow the IFU to manually enter barcode number 2 with "22" in place of "+$$" which is printed on the label.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre