# FDA recall Z-0220-2023

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2022-10-13.

## 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 for recall

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.

## Distribution

Worldwide Distribution: US (Nationwide) and Countries (Foreign) including: Australia Bermuda DV04 Bermuda, HM 13 Bermuda, HM08 Brazil Canada L3R 4G5  Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden United Kingdom

## Key facts

- **Recall number:** Z-0220-2023
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-13
- **Report date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0220-2023

## Citation

> AI Analytics. FDA recall Z-0220-2023. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0220-2023. Source: US FDA. Licensed CC0.

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