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Optilite C-Reactive Protein Kit - Product Usage: The… recallZ-0671-2020 · The Binding Site Group, Ltd. · initiated Feb 19, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Material/Component Contamination

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-0671-2020
Status
Terminated
Initiated by the company
Feb 19, 2019
Posted by the FDA
Dec 12, 2019
Recalling firm
The Binding Site Group, Ltd.
Quantity
10 kits
Product code
DCN
FDA submissions
K172868
Distribution
US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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