Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems 의 리콜

Recall

RC-2013-RN-01249-1

Class II

2013-11-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01249-1

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.

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.