Lower riskMedical device recall · FDA · Published July 25, 2018
Binding Site Human IgM Kit (SPAPLUS) recall: Reduced accuracy after calibration
Binding Site recalls Human IgM Kit (SPAPLUS) REF NK012.S due to reduced accuracy after calibration. Affected lots 407483-1 and 407483-2 may produce inaccurate results.
After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.
Take action
Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
“Binding Site Human IgM Kit (SPAPLUS) recall: Reduced accuracy after calibration.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70294-binding-site-human-igm-kit-spaplus-recall-reduced-accuracy-after. Based on FDA recall #Z-0477-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0477-2019%22&limit=1).
The Food and Drug Administration announced on July 25, 2018, that The Binding Site Group, Ltd. recalled the Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S due to accuracy issues. The device may produce control results out of range one day after running the assay calibration curve.
How to tell if you have it
Brand: The Binding Site
Product: Binding Site Human IgM Kit (for SPAPLUS)
REF: NK012.S
Lot codes: 407483-1 and 407483-2
The hazard
According to the FDA, after running the calibration curve, the recovery of the IgM kit control results decreases, demonstrating a reduction in accuracy within the same day. Control results may be out of range one day after running the assay calibration curve, and samples have been shown to be similarly affected.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has 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 Recall regarding calibration issues impacting sterility (January 7, 2026).
How to tell if you have this one
Check for the product name 'Binding Site Human IgM Kit (for SPAPLUS)' and reference number NK012.S. Affected lots are 407483-1 and 407483-2.
Brand
The Binding Site
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot
Verify the lot number is 407483-1 or 407483-2.
Where it went and when
Where it was distributed
Distributed in 14 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, Florida, Illinois, Indiana, Maryland, Nebraska, New Jersey, New York, North Carolina, Pennsylvania, South Dakota, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.8 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-0477-2019 (July 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0477-2019 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.