Cl ll VITROS ECi Immunodiagnostic System

Company:Ortho-Clinical Diagnostics
Date of Enforcement Report 5/2/12
Class ll:

PRODUCT
1) VITROS? ECi Immunodiagnostic System, Catalog No. 8633893 — COMMON/USUAL NAME: VITROS? ECi System. All systems that has Software Version 3.8 or below installed and on which the VITROS? Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens. Recall # Z-0923-2012

2) VITROS? ECiQ Immunodiagnostic System, Catalog No. 1922814 — COMMON/USUAL NAME: VITROS? ECiQ System. All systems that has Software Version 3.8 or below installed and on which the VITROS? Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens. Recall # Z-0924-2012

REASON
Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid Dilution (ID) code.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters on August 24, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
ECi: 1921 (Domestic 808, Foreign 1113); ECiQ: 2200 (Domestic 906, Foreign 1294)

DISTRIBUTION
Nationwide and Internationally

_____________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.