Reported Apr 19, 2017 · Terminated
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ORTHO-CLINICAL DIAGNOSTICS · FELINDRE MEADOWS · Bridgend, N/A · N/A
Is this the product you have?
- VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
- Lot codes and dates
Lot 1570 (expiry 22 March 2017)Lot 1580 (expiry 13 April 2017)Lot 1590 (expiry 27 April 2017)
- Amount recalled
- US: 6324; Foreign: 1868
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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