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.
The Binding Site is recalling Human IgM Kit (for SPAPLUS) REF NK012.S because it may cause calibration curve validation issues. This means control values could report outside the specified ranges, potentially affecting test accuracy.
The kit's control values may report outside the specified ranges during calibration curve validation. This could lead to inaccurate test results if the calibration curve is not properly validated.
Users of this laboratory test kit who validate calibration curves for SPAPLUS testing. Most at risk are lab technicians handling the kit.
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.
Verify if control values report outside the specified ranges during calibration curve validation.
The kit may cause calibration curve validation issues, indicated by control values reporting outside the specified ranges.
Check if control values report outside the specified ranges during calibration curve validation. If so, stop using the kit.
The recall record does not mention a fix or remedy.
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-0604-2019 — The Binding Site The Binding Site Hello, I own a The Binding Site that is covered by recall Z-0604-2019 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.
