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.
This recall has been terminated (originally issued March 9, 2018).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- March 9, 2018
- Terminated
- June 22, 2020
- Recall Number
- Z-1301-2018
- Quantity
- 20 kits distributed to the U.S.
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
Reason for Recall
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Distribution
US Distribution was made to CA. There was no foreign/military/government distribution.
Lot / Code Info
Lot 407460, UDI 05051700017688
Root Cause
Under Investigation by firm
Action Taken
The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.
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