---
title: "VITROS XT7600 Integrated System — FDA record Z-1222-2024 | Is It on Recall"
description: "Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 In"
url: https://isitonrecall.com/recall/fda-device-z-1222-2024-vitros-xt7600-integrated-system/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# VITROS XT7600 Integrated System — FDA record Z-1222-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: VITROS XT7600 Integrated System
- **Reason**: Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- **Classification**: Class II
- **Recalling firm**: Ortho-Clinical Diagnostics, Inc.
- **Quantity**: 1,720 units (834 US, 886 OUS)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1222-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1222-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive). |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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## Dates in the source

- **Report date**: Mar 13, 2024
- **Recall initiation date**: Jan 22, 2024
- **Center classification date**: Mar 1, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1222-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ortho-Clinical Diagnostics, Inc. records](https://isitonrecall.com/brand/ortho-clinical-diagnostics-inc/)