---
title: "cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, fo... — FDA record Z-0489-2025 | Is It on Recall"
description: "Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative"
url: https://isitonrecall.com/recall/fda-device-z-0489-2025-cobas-hcys-homocysteine-enzymatic-assay-material-number-ref-06542921190-for-use-on-cobas-c-701-702-i/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test ... — FDA record Z-0489-2025

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 Oct 17, 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**: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
- **Reason**: Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- **Classification**: Class II
- **Recalling firm**: Roche Diagnostics Operations, Inc.
- **Quantity**: 458 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0489-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0489-2025%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 | UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024 |

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

## Distribution

US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,

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

- [Florida](https://isitonrecall.com/state/florida/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Nov 27, 2024
- **Recall initiation date**: Oct 17, 2024
- **Center classification date**: Nov 19, 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-0489-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Roche Diagnostics Operations, Inc. records](https://isitonrecall.com/brand/roche-diagnostics-operations-inc/)