🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 18, 2020 The Binding Site Group Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
The Binding Site Group, Ltd.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: CO, FL, IA, MA, NC, NJ, NY, OH, SD, UT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0943-2021

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The Binding Site Group

Class I - Dangerous

It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.

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The Binding Site Group

Class I - Dangerous

Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

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