FDA Device recall Z-0689-2019
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only
- FDA Device
- Class II
- ongoing
- Published 2019-01-09
On 2019-01-09 the FDA classified a Class II recall of VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing 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 ar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0689-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-01 |
| Published | 2019-01-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | All expired, in-date, and future lots released. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0689-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.