# FDA recall Z-1500-2020

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2019-11-06.

## Product

Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

## Reason for recall

It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.

## Distribution

Distributed in CA.

## Key facts

- **Recall number:** Z-1500-2020
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-06
- **Report date:** 2020-03-25
- **Termination date:** 2022-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Birmingham, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2020

## Citation

> AI Analytics. FDA recall Z-1500-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1500-2020. Source: US FDA. Licensed CC0.

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