The Binding Site Group, Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0553-2018)

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:

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

Product Classification:

Class II

Date Initiated: January 4, 2018

Date Posted: February 14, 2018

Recall Number: Z-0553-2018

Event ID: 78934

Reason for Recall:

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

Status: Terminated

Product Quantity: 49 kits to the U.S. office (32 kits further distributed)

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.

Voluntary or Mandated:

Voluntary: Firm initiated