Exact FDA event identifier

Event 78934

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

Open FDA event record

Event summary

Timeline bucket: January 04, 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

Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings

Z-0553-2018

Recall number: Z-0553-2018
Initiated: January 04, 2018
Classification: Class II
Status: Terminated
Recalling firm: The Binding Site Group, Ltd.
Quantity: 49 kits to the U.S. office (32 kits further distributed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The low and high controls for the product are returning results above the assigned values.

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 low and high controls for the product are returning results above the assigned values.

Code information

Lot #416595, Exp. 31/03/2018; UDI #05051700018319

Distribution pattern

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