Optilite Freelite Mx Kappa Free Kit recallZ-0943-2021 · The Binding Site Group, Ltd. · initiated Nov 18, 2020

Terminated

Is my device affected?

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.
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.
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

Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

FDA root cause category: Under Investigation by firm

What the company is doing

On 11/30/2020, the firm emailed an "Urgent Field Safety Notice" to its U.S. Customers informing them that investigations have confirmed that the quality control (QC), high and low controls, provided with specific product and lot numbers are consistently demonstrating a ~15% positive bias compared to assigned values and customers may experience QCs consistently reporting results close to the upper acceptable limits, and QC failures may occur on the affected products. Customer are instructed: 1. Users may continue to use any remaining kits of the affected product in their stock. As per the product package insert sample results obtained should only be accepted if the control results are within +/-20% of the concentrations stated on the QC certificate provided. 2. To complete the E-Back Form TSWS18 to [email protected] or to their local representative within one week of receiving this notification. Customers are also instructed: -To pass on the notification to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. -To transfer this notification to other organizations on which the information has an impact. -To maintain awareness on this notification for any appropriate period. Any questions, contact the local representative or Technical Support Group: UK technical support is: Telephone: +44(0) 1214569696 Email: [email protected] Customers in the USA may choose to instead contact the local representative at: Telephone: 800-633-4484 [email protected]

Recall details

Recall number: Z-0943-2021
Status: Terminated
Initiated by the company: Nov 18, 2020
Recalling firm: The Binding Site Group, Ltd.
Quantity: 213 kits in the U.S.
Product code: DFH
FDA submissions: K173732
Distribution: U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided

Product description

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Code information (models, lots, serial numbers)

Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763

Devices named in this recall

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

Optilite Freelite Mx Kappa Free Kit LK016.M.OPT.A
The Binding Site Group Limited · Kappa, Antigen, Antiserum, Control
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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