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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00820-1
Product Name/Description	VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic medical device (IVD) VITROS Immunodiagnostic Products CA 19-9 Calibrators Product Code: 6800035 VITROS Immunodiagnostic Products CA 19-9 Reagent Pack Product Code: 6800040 Lot Number: 1320 Expiry Date: 12 September 2014
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/07/2014
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Ortho-Clinical Diagnostics (OCD) received complaints of results for patient and proficiency samples were elevated in some instances. Proficiency sample results when using VITROS CA 19-9 kit lot 1320, compared to previous kit lots used and analysed (OCD internal testing), found an overall average positive bias of approximately +30% for samples within the normal range (<=37 U/mL) and +17% for samples above the normal range (>37 U/mL).
Recall Action	Recall
Recall Action Instructions	Laboratories are being advised to immediately discontinue using and discard all remaining inventory of VITROS CA19-9 Calibrators and Reagent Packs, Lot 1320. Review previously reported results using VITROS CA 19-9 Reagent Packs, Lot 1320 and discuss any concerns regarding previously reported results with your Laboratory Medical Director or the requesting physician to determine the appropriate course of action. Ortho-Clinical Diagnostics (OCD) will provide credits/replace stock of any product affected by this recall. This action has been closed-out on 12/08/2016.
Contact Information	1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Service