Optilite Freelite Lambda Free Kit recallZ-1043-2017 · The Binding Site Group, Ltd. · initiated Jul 5, 2016
Class II Terminated All recalls posted in January 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1043-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 5, 2016
- Posted by the FDA
- Jan 18, 2017
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 809 kits
- Product code
- DEH
- FDA submissions
- K150658
- 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 description
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Code information (models, lots, serial numbers)
Lot #405566, 405567
Other devices under the same FDA submission
2 devices cleared under K150658 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Optilite Freelite Kappa Kit LK016.OPT.AThe Binding Site Group Limited · Kappa, Antigen, Antiserum, Control4 reports
- Optilite Freelite Lambda Kit LK018.OPT.AThe Binding Site Group Limited · Lambda, Antigen, Antiserum, Control2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page