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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00033-1
Product Name/Description	Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic medical device (IVD). Product Code: 6844210 ARTG Number: 180199
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	14/01/2015
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Ortho Clinical Diagnostics (OCD) has received a report that when using a Hand-held Barcode Scanner in combination with use of the Batch Programming option for programming samples, the scanner unexpectedly skips sample cup positions. For example, a sample tube barcode is scanned for the Cup 1 position, the cursor in the Batch programming screen skips the Cup 2 position and advances to the Cup 3 position. If this anomaly occurs, there is a potential for mis-associated results.
Recall Action	Recall for Product Correction
Recall Action Instructions	OCD is providing instructions on the reprogramming of the barcode scanner. Once the barcode scanner is reprogrammed the issue will not occur. This action has been closed-out on 15/07/2016
Contact Information	1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services