The Binding Site Group, Ltd.: Medical Device Recall in 2019 - (Recall #: Z-0671-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 19, 2019

Date Posted: December 18, 2019

Recall Number: Z-0671-2020

Event ID: 84243

Reason for Recall:

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

Status: Terminated

Product Quantity: 10 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated