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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01249-1
Product Name/Description	Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems Product Codes: 6802783, 6802413 ARTG Number: 180199 An in-vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/11/2013
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Ortho Clinical have received reports of condition codes that occurred during the calibration of MicroWell assays. Investigations have determined that the MicroWell Shuttle Weight may be uncoated and out of manufacturing specification. If an uncoated MicroWell Shuttle Weight is installed and calibration of MicroWell assays is performed, there is no effect on patient samples. If an uncoated MicroWell Shuttle Weight is installed and calibration is not performed, bias results could potentially occur. Internal testing has determined that quality control results using an uncoated well weight showed, on average 10% shift from established means within the quality control ranges. Ortho Clinical investigations has shown there is not likely to be any impact on patient safety, however, if the results are at or near a decision cut off or reference interval, this could potentially move the result into the incorrect result classification.
Recall Action	Recall for Product Correction
Recall Action Instructions	Ortho Clinical Diagnostics (OCD) is advising users that a service technician will be inspecting all systems to identify if an uncoated MicroWell Shuttle Weight is in use and replace any affected units. If an uncoated MicroWell Shuttle Weight is identified and replaced, all MicroWell assays are required to be recalibrated. This action has been closed-out on 02/02/2016.
Contact Information	1800 032 359 - Ortho Clincal Diagnostics Customer Technical Services