Recall Z-2030-2021— The Binding Site Group, Ltd.

Name: FDA recall Z-2030-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-20

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2021-05-20, terminated 2025-02-04. It names one FDA 510(k) clearance: K070900. 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. Reason: The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2021-05-20
Terminated: 2025-02-04
Firm location: Birmingham, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K070900 — FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KITThe Binding Site, Ltd.·cleared 2007-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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

Reason for recall

The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

Data sourced from openFDA. This site is unofficial and independent of the FDA.