VITROS Immunodiagnostic Products NT-pro BNP Reagent recall
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Why was VITROS Immunodiagnostic Products NT-pro BNP Reagent 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1570 (expiry 22 March 2017), Lot 1580 (expiry 13 April 2017), Lot 1590 (expiry 27 April 2017)
- Product
- VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- 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.
- Recall date
- April 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)