Recall record at a glance
| Official record | Z-0689-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Report date | Jan 9, 2019 |
| Recall initiation date | Nov 1, 2018 |
| Quantity | 46598 total, 46062 units in US (100 tests per unit) |
| Location | Bridgend, N/A, United Kingdom |
Official product description
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
Why the product was recalled
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
Distribution information
Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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