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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01238-1
Product Name/Description	VITROS Chemistry Products K+ Slides. An in vitro diagnostic medical device (IVD) Catalogue Number: 8157596 Coatings: 0884, 0885
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	21/11/2013
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	While performing an internal investigation, Ortho Clinical Diagnostics (OCD) determined that the coatings of the VITROS Chemistry Products K+ Slides contain a surfactant that was unintentionally added during the manufacturing process. The affected slides continue to meet intended use and performance specifications, however the long term product performance is unknown.
Recall Action	Recall
Recall Action Instructions	OCD is requesting their customers to discontinue use and discard all units from the affected lots. Replacement kits will be provided if required.
Contact Information	1800 032 359 - Ortho Clincal Diagnostics Customer Technical Services