FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022
  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:
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% 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:

FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

Product Codes/Lot Numbers:

Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2030-2021

Related Recalls

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.

Oct 15, 2021 Other Medical Devices View Details →

Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.

Oct 7, 2019 Infusion Pumps Nationwide View Details →