The Binding Site Group, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-1500-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

Product Classification:

Class II

Date Initiated: November 6, 2019

Date Posted: March 25, 2020

Recall Number: Z-1500-2020

Event ID: 84909

Reason for Recall:

It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.

Status: Terminated

Product Quantity: 30 kits

Code Information:

Lot 428217 (Expiry date: 30-APR-2020

Distribution Pattern:

Distributed in CA.

Voluntary or Mandated:

Voluntary: Firm initiated