The Binding Site Group, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2110-2020)

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:

Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)

Product Classification:

Class II

Date Initiated: October 7, 2019

Date Posted: June 3, 2020

Recall Number: Z-2110-2020

Event ID: 85366

Reason for Recall:

Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.

Status: Terminated

Product Quantity: 478 kits

Code Information:

Kit Lot Number: 428224

Distribution Pattern:

US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated