The Binding Site recalls C-Reactive Protein kits for SPAplus devices due to potential inaccurate test results for low concentrations. Affected kits may not detect samples below 10 mg/L correctly.
A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
The Binding Site is recalling C-Reactive Protein test kits for SPAplus devices because some kits may give inaccurate results for samples with concentrations of 10 mg/L or less. This could lead to incorrect health assessments if used for medical testing.
The test kit's reagent may not work correctly, causing samples with concentrations of 10 mg/L or less to be misread. This could lead to incorrect health assessments if the test is used for medical purposes.
Healthcare professionals using the C-Reactive Protein test kits for medical diagnostics on SPAplus devices are most at risk. Patients receiving these tests may have inaccurate results if the kit is used improperly.
Check for the product name 'C-Reactive Protein Kit for use on the SPAplus', reference number NK044.S.A, and lot number 455672. The kit is sold under the manufacturer's name The Binding Site Group, Ltd.
Verify the product name, reference number NK044.S.A, and lot number 455672 to confirm if your kit is affected.
The reagent in the C-Reactive Protein kit may not perform correctly, potentially causing inaccurate results for samples with concentrations of 10 mg/L or less.
The recall record does not specify a remedy, so check the product details to confirm if your kit is affected and contact The Binding Site Group, Ltd. for further guidance.
The recall indicates a potential for inaccurate test results, not a physical safety hazard like fire or injury.
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-1619-2020 — The Binding Site The Binding Site Hello, I own a The Binding Site that is covered by recall Z-1619-2020 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.
