FDA Device recall Z-2019-2024
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly
- FDA Device
- Class III
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class III recall of VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly by Ortho Clinical Diagnostics, citing the results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2019-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-05-08 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872
Reason
The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.
Identifiers
| code_info | UDI-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2019-2024%22
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