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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