FDA Device recall Z-0220-2023
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0220-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-13 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT
Reason
Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.
Identifiers
| code_info | UDI-DI: 10758750005031 Kit Lots/Exp. Date: 0911 24-MAY-2023; 0921 04-OCT-2023; 0942 06-JUN-2024; 0980 26-OCT-2022; 0991…UDI-DI: 10758750005031 Kit Lots/Exp. Date: 0911 24-MAY-2023; 0921 04-OCT-2023; 0942 06-JUN-2024; 0980 26-OCT-2022; 0991 01-MAR-2023 VITROS Chemistry Products PHYT Slides, GEN 22, All lots Calibration Diskette Data Release Versions (DRVs) 6194 through 6200 supporting VITROS Calibrator Kit 9. |
|---|
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-0220-2023%22
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