The Binding Site recalls Optilite C-Reactive Protein Kits due to potential reagent deterioration causing inaccurate test results. Affected kits include model NK044.OPT.A with lot 437705. Users should contact for guidance.
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
The Binding Site recalls Optilite C-Reactive Protein Kits because the reagent may deteriorate, leading to inaccurate test results. This could affect medical evaluations of infection, tissue injury, and inflammation. Users should stop using the kit if they have the affected model.
The reagent in the Optilite C-Reactive Protein Kit can deteriorate over time, causing inaccurate measurements of C-reactive protein levels. This may lead to incorrect medical evaluations of infection, tissue injury, or inflammation. The test should be used with other clinical findings for accurate results.
Healthcare professionals using the Optilite C-Reactive Protein Kit for medical testing are most at risk. Patients relying on these tests for infection or inflammation evaluation may also be affected.
Check for model number NK044.OPT.A with lot number 437705. The kit includes a unique device identifier (UDI) starting with 05051700018449.
Verify the model number NK044.OPT.A and lot number 437705 on the kit packaging.
The reagent in the Optilite C-Reactive Protein Kit may deteriorate, causing inaccurate test results for C-reactive protein levels.
The official recall notice does not specify a remedy or action steps for affected kits.
The recall indicates potential reagent deterioration, so it is not recommended for use until the manufacturer provides guidance.
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-0671-2020 — The Binding Site The Binding Site Hello, I own a The Binding Site that is covered by recall Z-0671-2020 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.
