Z-1050-2017Class II

Human Lambda Free SPAPlus Kit

Name: Z-1050-2017 Human Lambda Free SPAPlus Kit
Creator: The Binding Site Group, Ltd.
Published: 2012-11-28
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2012-11-28 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases on 2012-11-28. FDA classified it as Class II and gives the reason as "Calibration curve activity has increased over time in the kit lots listed". 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-1050-2017
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Posted: 2017-01-19
Terminated: 2017-03-03
Recalling firm: The Binding Site Group Ltd.
Product: Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Product code: DEH Lambda, Antigen, Antiserum, Control
Reason for recall: Calibration curve activity has increased over time in the kit lots listed.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.
Quantity in commerce: 1,002
Distribution: U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
Product codes and lots: Lot #323278, 327963

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1050-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1050-2017	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)