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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Tampa, FL 33624
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Partners located in the US (CA, FL, MA, MN) and Italy.