---
title: "Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative me... — FDA record Z-2152-2025 | Is It on Recall"
description: "A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity"
url: https://isitonrecall.com/recall/fda-device-z-2152-2025-estrone-ria-ref-dsl8700-estrone-ria-is-an-ivd-used-for-the-quantitative-measurement-of-estrone-in-hu/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and ... — FDA record Z-2152-2025

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 Jun 12, 2025. 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**: Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
- **Reason**: A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
- **Classification**: Class II
- **Recalling firm**: Beckman Coulter Inc.
- **Quantity**: 496 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2152-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2152-2025%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: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C |

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

## Distribution

US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands

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

- [North Carolina](https://isitonrecall.com/state/north-carolina/)

## Dates in the source

- **Report date**: Jul 30, 2025
- **Recall initiation date**: Jun 12, 2025
- **Center classification date**: Jul 21, 2025

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-2152-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Beckman Coulter Inc. records](https://isitonrecall.com/brand/beckman-coulter-inc/)