Device 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.
Z-1301-2018
Product summary
- Event
- Event 79499
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 kits distributed to the U.S.
- Official record key
device-enforcement:Z-1301-2018
Official wording
Reason: The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Code information: Lot 407460, UDI 05051700017688
Distribution pattern: US Distribution was made to CA. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.