Lower riskMedical device recall · FDA · Published November 6, 2018
Binding Site Human IgM Kit Recall: Calibration Curve Validation Issues
The Binding Site recalls Human IgM Kit (for SPAPLUS) REF NK012.S due to calibration curve validation problems. Kit control values may report outside specified ranges.
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
Take action
Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
“Binding Site Human IgM Kit Recall: Calibration Curve Validation Issues.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69493-binding-site-human-igm-kit-recall-calibration-curve-validation-issues. Based on FDA recall #Z-0604-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0604-2019%22&limit=1).
The FDA announced on November 6, 2018, that The Binding Site Group, Ltd. voluntarily recalled the Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S due to calibration curve validation challenges. The device may report control values outside specified ranges.
How to tell if you have it
Brand: The Binding Site
Product: Binding Site Human IgM Kit (for SPAPLUS)
REF: NK012.S
Lot: 413849
The hazard
The firm reported that customers may experience challenges validating the calibration curve of the IgM kits. This issue is indicated by kit control values reporting outside the specified ranges.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has had 15 other recalls on record since August 23, 2017. Other recent recalls of similar products include EXENT Analyser Software Version 1.0.20 (April 16, 2026), Freelite Human Lambda Free Kit (October 15, 2021), and FREELITE Human Kappa Free Kit (May 20, 2021). Other recent recalls of similar products include Medline Convenience Kits (January 7, 2026), Medline PPE Kit DYK1011945P (January 7, 2026), and Medline Convenience Kits (January 7, 2026).
How to tell if you have this one
Look for the product name 'Binding Site Human IgM Kit (for SPAPLUS)' with reference number NK012.S. The kit contains reaction buffer, sheep anti-IgM, calibrators, and controls.
Brand
The Binding Site
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Results
Verify if control values report outside the specified ranges during calibration curve validation.
Where it went and when
Where it was distributed
Distributed in 10 states.
Listed by the agency
Not listed
FDA distribution: “U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Illinois, Indiana, Nebraska, New York, Pennsylvania, South Dakota, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0604-2019 (November 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0604-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.