Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00061-1
Product Name/Description VITROS Vapor Adsorption Cartridge. An in vitro diagnostic medical device (IVD).

Product codes 6800100 and 1H5419

Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 22/01/2013
Responsible Entity Ortho-Clinical Diagnostics
Reason/Issue There is the potential for VITROS Vapor Adsorption Cartridges sales unit cartons to incorrectly contain a Particulate Cartridge (part number J19612)
Recall Action Recall
Recall Action Instructions Ortho Clinical Diagnostics (OCD) is requesting end users to ensure that a VITROS Vapour Adsorption Cartridge is installed. If a Particulate Cartrtigde is installed it must be replaced immediately with the correct cartridge and reported to OCD Customer Technical Services. Results generated while a Particulate Cartridge was installed must be reviewed. Any concerns with previously reported patient results should be discussed with the laboratory director to determine the appropriate course of action.
Contact Information 1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Services