Z-1043-2017Class II

Optilite Freelite Lambda Free Kit

Name: Z-1043-2017 Optilite Freelite Lambda Free Kit
Creator: The Binding Site Group, Ltd.
Published: 2016-07-05
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2016-07-05 / Terminated

FDA source

The Binding Site Group, Ltd. began a recall of Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit on 2016-07-05. FDA classified it as Class II and gives the reason as "Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1043-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-05
Posted: 2017-01-18
Terminated: 2017-07-03
Recalling firm: The Binding Site Group Ltd.
Product: Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Product code: DEH Lambda, Antigen, Antiserum, Control
Reason for recall: Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
FDA root cause: Under Investigation by firm
Action: On 07/05/16 notification letters were sent to customers. The Binding Site Group requests the following: - Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock; - Remove any affected lots from the Optilite instrument; - Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable; - Notify local Binding Site representative to request replacement kits; - Return completed E-Back Form to local Binding Site Representative; The firm recommended that the notice be circulated to those within the organization who need to be aware.
Quantity in commerce: 809 kits
Distribution: U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.
Product codes and lots: Lot #405566, 405567

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1043-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1043-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

Product code DEH

K150658Class IIOptilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitThe Binding Site Group , Ltd. / cleared 2015-08-26

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)