# FDA recall Z-0553-2018

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2018-01-04.

## Product

Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A    Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings

## Reason for recall

The low and high controls for the product are returning results above the assigned values.

## Distribution

US Distribution was made to CA.  There was no foreign/military/government distribution.

## Key facts

- **Recall number:** Z-0553-2018
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-04
- **Report date:** 2018-02-14
- **Termination date:** 2020-06-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0553-2018

## Citation

> AI Analytics. FDA recall Z-0553-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0553-2018. Source: US FDA. Licensed CC0.

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