---
title: "VITROS Performance Verifier II — FDA record Z-1373-2024 | Is It on Recall"
description: "The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Qua"
url: https://isitonrecall.com/recall/fda-device-z-1373-2024-vitros-performance-verifier-ii/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# VITROS Performance Verifier II — FDA record Z-1373-2024

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 Feb 27, 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 Performance Verifier II
- **Reason**: The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- **Classification**: Class II
- **Recalling firm**: Ortho-Clinical Diagnostics
- **Quantity**: 11,224 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1373-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1373-2024%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 | Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176. |

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, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

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## Dates in the source

- **Report date**: Apr 3, 2024
- **Recall initiation date**: Feb 27, 2024
- **Center classification date**: Mar 22, 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-1373-2024%22)

## Related records

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