The Binding Site Group, Ltd.: Medical Device Recall in 2018 - (Recall #: Z-1301-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 9, 2018

Date Posted: April 11, 2018

Recall Number: Z-1301-2018

Event ID: 79499

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.

Status: Terminated

Product Quantity: 20 kits distributed to the U.S.

Code Information:

Lot 407460, UDI 05051700017688

Distribution Pattern:

US Distribution was made to CA. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated