Lower risk Medical device recall · FDA · Published July 29, 2019

OPTILITE IgM Kit Recall: Calibration Issues May Cause False Results

The Binding Site Group recalls OPTILITE IgM Kit (REF: NK012.OPT.A) due to potential calibration errors that could lead to false patient results and delayed testing.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1327-2020Medical device The Binding Site Group ›

Lower-risk 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.

Take action

Contact the company

Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom

✎ GovInfoNow plain-language explainer

The Binding Site Group recalls their OPTILITE IgM Kit (REF: NK012.OPT.A) because it may not validate properly, causing false test results and delays in patient care. This could affect lab users who rely on the kit for accurate diagnostics. Read more at govinfonow.com/recall/67294-optilite-igm-kit-recall-calibration-issues-may-cause-false-results.

Source Summary by GovInfoNow · govinfonow.com/recall/67294-optilite-igm-kit-recall-calibration-issues-may-cause-false-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1327-2020

Cite this page

“OPTILITE IgM Kit Recall: Calibration Issues May Cause False Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67294-optilite-igm-kit-recall-calibration-issues-may-cause-false-results. Based on FDA recall #Z-1327-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1327-2020%22&limit=1).

The FDA announced on 2019-07-29 that The Binding Site Group, Ltd. is recalling the OPTILITE IgM Kit due to potential calibration validation difficulties. This issue may lead to false patient results and testing delays.

How to tell if you have it

Brand: The Binding Site Group
Product: OPTILITE IgM Kit
REF: NK012.OPT.A
UDI: 05051700017565
Lot #: 422251

The hazard

Users may experience difficulty validating the kit's calibration, indicated by control values reporting outside specified ranges. This could result in false patient results which could cause a delay until repeat testing is performed.

Context

GovInfoNow's records show The Binding Site Group, Ltd. has 15 other recalls on record since 2017-08-23. Other recent recalls of similar products include EXENT Analyser Software Version 1.0.20 (2026-04-16) and Freelite Human Lambda Free Kit Recall (2021-10-15).

How to tell if you have this one

Check for the kit reference number NK012.OPT.A and lot number 422251 on the product packaging. The recall applies to kits sold with this specific lot number.

Brand
The Binding Site Group
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the product reference number NK012.OPT.A and lot number 422251 on the kit packaging.

Where it went and when

Where it was distributed

Distributed in 28 states.

FDA 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,” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, West Virginia.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Jul 29, 2019Firm started the recall
Feb 19, 2020FDA classified it Class II
Feb 26, 2020Published in FDA’s Enforcement Report
Jan 13, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More The Binding Site Group recalls

Link to this recall

<a href="https://govinfonow.com/recall/67294-optilite-igm-kit-recall-calibration-issues-may-cause-false-results">OPTILITE IgM Kit Recall: Calibration Issues May Cause False Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1327-2020 (July 29, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1327-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.