Lower riskMedical device recall · FDA · Published April 25, 2019
The Binding Site C-Reactive Protein Kit Recall: Inaccurate Test Results
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
Take action
Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
“The Binding Site C-Reactive Protein Kit Recall: Inaccurate Test Results.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/68023-the-binding-site-c-reactive-protein-kit-recall-inaccurate-test. Based on FDA recall #Z-1619-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1619-2020%22&limit=1).
The FDA announced on April 25, 2019, that The Binding Site Group, Ltd. voluntarily recalled a C-Reactive Protein Kit for use on the SPAplus due to reagent performance issues. The agency classified the recall as Class II.
How to tell if you have it
Brand: The Binding Site
Product: C-Reactive Protein Kit for use on the SPAplus
REF: NK044.S.A
UDI: (01)05051700018456
Lot: 455672
UPC: 05051700018456
The hazard
According to the FDA, a reagent in the C-Reactive Protein Kit is not performing to specification. Samples with known concentrations less-than-or-equal to 10 mg/L may be affected by this defect.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has 15 other recalls on record since August 23, 2017. Recent brand recalls include the EXENT Analyser Software Version 1.0.20 (April 16, 2026) and the Freelite Human Lambda Free Kit (October 15, 2021). Other recent recalls of similar products include the Siemens Dimension Creatinine Flex Reagent Cartridge Recall (March 18, 2026), the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), and the Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
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.
Brand
The Binding Site
Product
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the product name, reference number NK044.S.A, and lot number 455672 to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed in Florida.
Listed by the agency
Not listed
FDA distribution: “U.S.: FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1619-2020 (April 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1619-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.