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.
The Binding Site recalls its Human IgM Kit for SPAPLUS (REF NK012.S) because running a calibration curve causes the control results to become less accurate within the same day. This could lead to incorrect test results for samples.
After running the calibration curve, the kit's control results become less accurate within the same day. This reduction in accuracy can cause test results to be out of range one day later. Samples processed after this point may also be affected.
Users of the Binding Site Human IgM Kit for SPAPLUS are affected. Laboratory personnel who run the calibration curve daily are most at risk of inaccurate results.
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.
Verify the lot number is 407483-1 or 407483-2.
The recall is due to reduced accuracy in control results after running the calibration curve, which can lead to out-of-range results one day later.
The control results may become less accurate within the same day, potentially causing test results to be out of range one day after calibration.
Look for the product name 'Binding Site Human IgM Kit (for SPAPLUS)' and reference number NK012.S with lot numbers 407483-1 or 407483-2.
We’ve drafted a message you can send The Binding Site to request your refund or repair — edit it as you like.
Subject: Recall Z-0477-2019 — The Binding Site The Binding Site Hello, I own a The Binding Site that is covered by recall Z-0477-2019 from The Binding Site. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
