FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: 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.
- Recall number
- Z-1301-2018
- Recalling firm
- The Binding Site Group, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2018-03-09
- Posted
- not on file
- Terminated
- 2020-06-22
- Reason
- The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.
- Quantity
- 20 kits distributed to the U.S.
- Distribution
- US Distribution was made to CA. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot 407460, UDI 05051700017688
- 510(k) numbers
- ["K122066"]
- PMA numbers
- not on file
- Product code
- JZG
- Firm FEI
- 3002808340
- Firm city
- Birmingham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28