---
title: "Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23... — FDA record Z-2976-2026 | Is It on Recall"
description: "Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measureme"
url: https://isitonrecall.com/recall/fda-device-z-2976-2026-beckman-coulter-emit-2000-quinidine-assay-ref-osr4q229-contents-r1-2-x-23-ml-r2-2x13-ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL — FDA record Z-2976-2026

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 Jul 13, 2026. 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**: Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
- **Reason**: Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
- **Classification**: Class II
- **Recalling firm**: Siemens Healthcare Diagnostics, Inc.
- **Quantity**: 55 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2976-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2976-2026%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 | Lots: 2597, 2627, 2709/UDI: 00842768023293 |

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

## Distribution

Worldwide - US Nationwide distribution in the state of CA and the country of Italy.

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**: Aug 26, 2026
- **Recall initiation date**: Jul 13, 2026
- **Center classification date**: Aug 17, 2026

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-2976-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Siemens Healthcare Diagnostics, Inc. records](https://isitonrecall.com/brand/siemens-healthcare-diagnostics-inc/)
