Recall Z-1050-2017— The Binding Site Group, Ltd.

Name: FDA recall Z-1050-2017
Creator: U.S. Food and Drug Administration
Published: 2012-11-28

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2012-11-28, terminated 2017-03-03. It names one FDA 510(k) clearance: K062372. Product: Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.. Reason: Calibration curve activity has increased over time in the kit lots listed..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Terminated: 2017-03-03
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

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

Reason for recall

Calibration curve activity has increased over time in the kit lots listed.

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