CLASS II Device recall · Reported 18 Dec 2019 · FDA Enforcement Report

Optilite C-Reactive Protein Kit recalled by The Binding Site Group

The Binding Site Group is recalling Optilite C-Reactive Protein Kit, distributed nationwide in the US. The recall was initiated on 19 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086

Quantity recalled10 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0671-2020
FDA event ID: 84243
Recalling firm: The Binding Site Group, Birmingham, N/A
Classification: Class II
Status: Terminated
Recall initiated: 19 Feb 2019
FDA classified: 12 Dec 2019
Reported: 18 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

19 Feb 2019	Recall initiated by company
12 Dec 2019	Classified by FDA	+296 days
18 Dec 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

Product as listed by the FDA

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

Where it was distributed

US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS

Nationwide California Georgia

Questions about this recall

Why was it recalled?

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

Which lots are affected?

Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086

Where was it sold?

US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from The Binding Site Group

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14 Jul 2021Device	CLASS II	Freelite Human Kappa Free Kit recalled by The Binding Site Group	The Binding Site Group	Other	Nationwide
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