FDAFDA · Food and drugs·Recall number 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., 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.
Published April 11, 2018 · Recall initiated: March 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- US Distribution was made to CA. There was no foreign/military/government distribution.
- Lot
- Lot 407460, UDI 05051700017688
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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