The Recall Desk
HighFDA (Devices)·Z-2030-2021·Announced 2021-07-14

FREELITE Kappa Free Kit quality control bias recall

The Binding Site Group is recalling the FREELITE Human Kappa Free Kit due to quality control bias of approximately 10% compared to assigned values. Specific lot numbers distributed worldwide are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device where quality control bias could affect diagnostic test reliability. No reported illnesses, injuries, or deaths; therefore scored at the maximum per rubric guidance for risk-of-harm products where injury has not been reported.

Plain-English summary

The FREELITE Human Kappa Free Kit for use on Roche cobas c Systems is being recalled by The Binding Site Group, Ltd. This is an in vitro diagnostic device with reference LK016.CB.

The recall is due to a quality control issue. The high and low level quality controls demonstrate a positive bias of approximately 10% compared to their assigned values.

The affected product was distributed worldwide, including throughout the United States and to Canada, Australia, and numerous other countries. Specific affected lot numbers are 487719 (expiration July 31, 2022), 480133 (expiration September 30, 2022), and 457890 (expiration September 30, 2022).

Healthcare facilities and laboratories that received affected lot numbers should contact The Binding Site Group, Ltd. for guidance regarding the recall.

The recalled product

Product
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
Manufacturer
The Binding Site Group, Ltd.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • quality-control-bias

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category