Optilite CRP Kit Recall: Deteriorated Reagent May Give False Results
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.
Lower-risk recall
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/68987-optilite-crp-kit-recall-deteriorated-reagent-may-give-false-results.
Source Summary by GovInfoNow · govinfonow.com/recall/68987-optilite-crp-kit-recall-deteriorated-reagent-may-give-false-results · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0671-2020
Cite this page
“Optilite CRP Kit Recall: Deteriorated Reagent May Give False Results.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68987-optilite-crp-kit-recall-deteriorated-reagent-may-give-false-results. Based on FDA recall #Z-0671-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0671-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for model number NK044.OPT.A with lot number 437705. The kit includes a unique device identifier (UDI) starting with 05051700018449.
- Brand
The Binding Site- Category
Medical device
What to do — step by step
Check Kit Details
Verify the model number NK044.OPT.A and lot number 437705 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this kit safe to use?
The recall indicates potential reagent deterioration, so it is not recommended for use until the manufacturer provides guidance.
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Where this comes from
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-0671-2020 (February 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0671-2020 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.