# FDA recall Z-1301-2018

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2018-03-09.

## Product

Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.  The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K.    The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.

## Reason for recall

The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

## Distribution

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

## Key facts

- **Recall number:** Z-1301-2018
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-09
- **Report date:** 2018-04-11
- **Termination date:** 2020-06-22

- **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-1301-2018

## Citation

> AI Analytics. FDA recall Z-1301-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1301-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*