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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01376-1
Product Name/Description VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD).

Product Code: 6801896

Lot Number: 2576

Expiry Date: 02 Sept 2017

ARTG Number: 232248
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 18/10/2016
Responsible Entity Ortho-Clinical Diagnostics Australia Pty Ltd
Reason/Issue Ortho Clinical Diagnostics has confirmed that some barcode labels included in some VITROS Calibrator Kit 25, Lot 2576 cartons contain an incorrect lot number. The labels indicate Lot 2575 instead of the correct Lot 2576 for all three calibrator levels. The printed barcode labels are used with the automatic calibration feature when calibrating VITROS 4600 or 5600 Systems. When the operator attempts to use the affected barcode labels to calibrate VITROS dHDL Slides, a ‘PZC-006’ condition code occurs, indicating that the Calibrator Lot is not supported by the Assay Data Disk (ADD); therefore the calibration is not successful. All labelling on the calibrator vials and the carton is correct. Lot 2576 calibrators perform as expected if the operator manually programs the correct lot information for calibration.
Recall Action Recall for Product Correction
Recall Action Instructions Ortho is advising users to inspect the barcode labels provided in VITROS Calibrator Kit 25, Lot 2576, discard affected labels that indicate Lot 2575, and to manually program Lot 2576 when calibrating VITROS dHDL Slides.

This action has been closed out on 01/11/2018
Contact Information 1800 032 359 - Ortho Care Technical Solutions Centre