The Binding Site Group, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-1327-2020)

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 IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

Product Classification:

Class II

Date Initiated: July 29, 2019

Date Posted: February 26, 2020

Recall Number: Z-1327-2020

Event ID: 84729

Reason for Recall:

There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

Status: Terminated

Product Quantity: 3294 kits

Code Information:

Lot # 422251

Distribution Pattern:

CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,

Voluntary or Mandated:

Voluntary: Firm initiated