Recall Z-1765-2017
Ortho-Clinical Diagnostics · initiated March 7, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Codes / lots: Lot 1570 (expiry 22 March 2017), Lot 1580 (expiry 13 April 2017), Lot 1590 (expiry 27 April 2017)
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1765-2017
- Initiated
- March 7, 2017
- Terminated
- June 14, 2019
- Product code
- NBC – Test, Natriuretic Peptide
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Bridgend