VITROS Chemistry Products CDM PROM Cl II

Company: Ortho-Clinical Diagnostics
Date of Enforcement Report 4/30/2014
Class lI:

PRODUCT

VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD — Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
Recall Number Z-1490-2014

REASON
Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC..

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 1/29/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
US: 284 units, Ex-US: 4772 units

DISTRIBUTION
Nationwide and Internationally

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