FDA Device recall Z-1664-2023
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions…
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions… by Ortho Clinical Diagnostics, citing unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1664-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-14 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
Reason
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Identifiers
| code_info | UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1664-2023%22
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