# FDA recall Z-1327-2020

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2019-07-29.

## Product

OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

## Reason for recall

There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

## Distribution

CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,

## Key facts

- **Recall number:** Z-1327-2020
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-29
- **Report date:** 2020-02-26
- **Termination date:** 2022-01-13

- **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-1327-2020

## Citation

> AI Analytics. FDA recall Z-1327-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1327-2020. Source: US FDA. Licensed CC0.

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