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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00254-1
Product Name/Description	VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital) GEN 38. Coating 0060 GEN 39. Coating 0062 GEN 40. Coating 0063 GEN 41. Coating 0064 Expiry date range: 1 April 2013 through 1 February 2014
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	19/03/2013
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Ortho Clinical Diagnostics has received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. An investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Recall Action	Recall
Recall Action Instructions	End users are requested to discard all lots of VITROS PHBR Slides. It is recommended that any concerns with previously reported patient results be discussed with the laboratory director and requesting physician.
Contact Information	1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Services