Z-1053-2017Class II

Freelite Human Lambda Free Kit for use on SPAPLUS

Name: Z-1053-2017 Freelite Human Lambda Free Kit for use on SPAPLUS
Creator: The Binding Site Group, Ltd.
Published: 2016-10-28
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2016-10-28 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of 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... on 2016-10-28. FDA classified it as Class II and gives the reason as "A change in the calibration curve causing an increase in false prozone flags". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1053-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-28
Posted: 2017-01-19
Terminated: 2017-07-27
Recalling firm: The Binding Site Group Ltd.
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
Product code: DEH Lambda, Antigen, Antiserum, Control
Reason for recall: A change in the calibration curve causing an increase in false prozone flags.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Binding Site sent an Important Notice dated October 28, 2016, to all affected customers. . Binding Site requests the following: - Immediately quarantine and dispose of any LK018.S lot 400012 / LK018.10S lot 400257 kits held in your organisation; - Remove any affected lots from the SPAPLUS instrument; - Contact Binding Site representative to request replacement kits; - Return completed E-back form to your local Binding Site representative. For questions regarding this recall call 858-453-9177.
Quantity in commerce: 3,088
Distribution: Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Product codes and lots: Lot #400012, 400257

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1053-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1053-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-19

Product code DEH

K062372Class IIFreelite Human Kappa and Lambda Free Kits for Use on the Spaplus AnalyzerThe Binding Site, Ltd. / cleared 2007-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)