Optilite IgG4 Kit Product Code: LK009 — Class III medical device recall Z-1089-2017
Terminated recall by The Binding Site Group, Ltd., reported 2017-02-01, distributed in CA, CT, FL, MA, MI, PA, TX, WA. A change to the lower end of the measuring range and product insert did not reflect the change.The measuring r
| Recall number | Z-1089-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom |
| Recall initiated | 2016-12-23 |
| Classified | 2017-01-24 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-05-03 |
| Distributed | CA, CT, FL, MA, MI, PA, TX, WA |
| Quantity | 9 users |
| Lot numbers | 401413 |
Product
Optilite IgG4 Kit Product Code: LK009.OPT.A
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1089-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.