FDA Device recall Z-0844-2019
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3…
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3… by Ortho Clinical Diagnostics, citing A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0844-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-29 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
Reason
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Identifiers
| code_info | Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0844-2019%22
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