# FDA recall Z-2110-2020

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2019-10-07.

## Product

Optilite Optilite Rheumatoid Factor Kit, Ref:  LK151.OPT.A, IVD, Rx Only, UDI:  05051700020015 (kit ea. containing four components)

## Reason for recall

Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum.  This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.

## Distribution

US:  AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI  OUS:  None

## Key facts

- **Recall number:** Z-2110-2020
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-07
- **Report date:** 2020-06-03
- **Termination date:** 2022-01-11

- **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-2110-2020

## Citation

> AI Analytics. FDA recall Z-2110-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2110-2020. Source: US FDA. Licensed CC0.

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