FDA Device recall Z-1089-2017
Optilite IgG4 Kit Product Code: LK009.OPT.A
- FDA Device
- Class III
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class III recall of Optilite IgG4 Kit Product Code: LK009.OPT.A by The Binding Site Group, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1089-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-23 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | CA, CT, FL, MA, MI, PA, TX, WA |
Product
Optilite IgG4 Kit Product Code: LK009.OPT.A
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
Identifiers
| code_info | Lot #401413 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1089-2017%22
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