Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent Packs Due to Calibration Failures
Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP Reagent Packs because background signals are increasing, causing calibration failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional defect (calibration failure) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products NT-proBNP Reagent Packs (REF/Catalog 680 2156). The affected lots are 1570, 1580, and 1590. The recall covers 6,324 units in the United States and 1,868 units in foreign markets.
The recall is due to an increased frequency of calibration failures. Background signals for these specific lots have been increasing over time since release testing. This results in higher-than-expected signals from the level 1 calibrator, which leads to the calibration failures.
The affected products were distributed worldwide, including in the United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela. Users should stop using the affected reagent packs and contact the manufacturer for instructions.
The recalled product
- Product
- VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 1570 (expiry 22 March 2017)
- Lot 1580 (expiry 13 April 2017)
- Lot 1590 (expiry 27 April 2017)
Distribution
Distributed in 1 state:
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