FDA Device recall Z-0772-2024
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrat…
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrat… by Ortho Clinical Diagnostics, citing affected lots may experience increased calibration failures or an increase in falsely elevated results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0772-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-27 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Reason
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Identifiers
| code_info | UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990 |
|---|
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-0772-2024%22
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