Exact FDA event identifier

Event 79499

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 09, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: The Binding Site Group, Ltd.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1301-2018

Recall number: Z-1301-2018
Initiated: March 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: The Binding Site Group, Ltd.
Quantity: 20 kits distributed to the U.S.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot 407460, UDI 05051700017688

Distribution pattern

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