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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