Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref… recallZ-1301-2018 · The Binding Site Group, Ltd. · initiated Mar 9, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.
Recall details
- Recall number
- Z-1301-2018
- Status
- Terminated
- Initiated by the company
- Mar 9, 2018
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 20 kits distributed to the U.S.
- Product code
- JZG
- FDA submissions
- K122066
- Distribution
- US Distribution was made to CA. There was no foreign/military/government distribution.
Product description
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.
Code information (models, lots, serial numbers)
Lot 407460, UDI 05051700017688
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Optilite Beta 2 Microglobulin Urine Kit LK043.L.OPT.AThe Binding Site Group Limited · System, Test, Beta-2-Microglobulin Immunological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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