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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