The Binding Site Group, Ltd.: 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.

Recall number

Z-0671-2020

Recalling firm

The Binding Site Group, Ltd.

Product

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.

Status

Terminated

Initiated

2019-02-19

Posted

2019-12-12

Terminated

2021-04-27

Reason

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

Root cause

Material/Component Contamination

Action

On 02/19/2019 an "URGENT FIELD SAFETY NOTICE" was communicated to the US customers informing them of an observed deterioration of the CRP NK044.OPT.A reagent material, lot number 437705 and that the Recalling firm has made the decision to remove the affected product lot from the market.. The Customers are instructed to: -Discontinue using the product immediately and to remove any remaining affected reagents from the Optilite instrument. -Dispose of any remaining product at the customer's facility following local regulations, -The Recalling Firm considers this issue is unlikely to impact on medical management, they are recommending that the information be discussed with the customer's medical director so that potential Impact of the issue is considered on a local level. -Customer are to complete, sign and return the E-Back Form TSWS18 to Technical.support@bindingsite.com or to their local representative within one week of receiving the notification. A witness signature of the kit disposal is required on the E-Back Form. The notification also states to: -Distribute the notice to all those who need to be aware of the matter within the customer's organization. -Transfer the notice to any other organization on which the recall action has impacted. -Maintain awareness on the notice and resulting action for appropriate period to ensure effectiveness of the recommended actions. For any questions or further information - contact the local firm representative or call +44(0) 1214569696

Quantity

10 kits

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K172868"]

PMA numbers

not on file

Product code

DCN

Firm FEI

3002808340

Firm city

Birmingham

Firm state

not on file

Firm country

United Kingdom

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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