Class III — 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 III |
| Status | Terminated |
| Reason | A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert |
| Product | Optilite IgG4 Kit Product Code: LK009.OPT.A |
| Quantity | 9 users |
| Distribution | U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution. |
| Initiated | 2016-12-23 |
| Classified | 2017-01-24 |
| Terminated | 2017-05-03 |
| Recall number | Z-1089-2017 |
| 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 III recall — The Binding Site Group, Ltd. (Z-1089-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76131/
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