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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.

FDA Recall Z-1301-2018 · Posted None

Recalling FirmThe Binding Site Group, Ltd.
Recall StatusTerminated
Product CodeJZG
Date Initiated2018-03-09
Date Terminated2020-06-22
Product Quantity20 kits distributed to the U.S.

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.

Firm Action

The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd. · 2012-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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