Recall Z-1053-2017— The Binding Site Group, Ltd.

Name: FDA recall Z-1053-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-28

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2016-10-28, terminated 2017-07-27. It names one FDA 510(k) clearance: K062372. Product: Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases. Reason: A change in the calibration curve causing an increase in false prozone flags..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-10-28
Terminated: 2017-07-27
Firm location: Birmingham, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K062372 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZERThe Binding Site, Ltd.·cleared 2007-06-21

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 Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases

Reason for recall

A change in the calibration curve causing an increase in false prozone flags.

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