FDA Device recall Z-1301-2018
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Bi…
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Bi… by The Binding Site Group, citing the product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1301-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-09 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | CA |
Product
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
Reason
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Identifiers
| code_info | Lot 407460, UDI 05051700017688 |
|---|
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-1301-2018%22
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