Cl II VITROS Immunodiagnostic Products

Company:ORTHO-CLINICAL DIAGNOSTICS
Date of Enforcement Report 4/192017
Class lI:

PRODUCT

VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD — Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Recall Number Z-1765-2017

REASON
Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.

RECALLING FIRM/MANUFACTURER
ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS ,Bridgend, United Kingdom on 3/7/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
US: 6324; Foreign: 1868

DISTRIBUTION
Nationwide and Internationally

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Software Verification

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Corporate Office

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