PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 11, 2018 Initiated: March 9, 2018 #Z-1301-2018

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.

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.

Details

Units Affected
20 kits distributed to the U.S.
Distribution
US Distribution was made to CA. There was no foreign/military/government distribution.
Location
Birmingham, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by The Binding Site Group, Ltd.. Units affected: 20 kits distributed to the U.S..
Why was this product recalled? ▼
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1301-2018.

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