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
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