Class II — The Binding Site Group, Ltd.
| Recalling firm | THE BINDING SITE, INC. |
|---|---|
| Registered facility | THE BINDING SITE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit. |
| Quantity | 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. |
| Initiated | 2016-07-05 |
| Classified | 2017-01-18 |
| Terminated | 2017-07-03 |
| Recall number | Z-1043-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — The Binding Site Group, Ltd. (Z-1043-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76048/
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