Recall Z-1765-2017 ยท NBC Test, Natriuretic Peptide
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
| Date | Mar 7, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 3/7/2017, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-048) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers and distributors who were shipped VITROS NT-proBNP Reagent Packs, Lots 1570, 1580 and/or 1590 to inform them of the issue and provided further instructions. |
| Quantity | US: 6324; Foreign: 1868 |
| Distribution | Worldwide: United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060632 | VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 Ortho-Clinical Diagnostics, Inc., Jun 6, 2006 |