The Binding Site Group, Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0477-2019)

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:

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

Product Classification:

Class II

Date Initiated: July 25, 2018

Date Posted: November 28, 2018

Recall Number: Z-0477-2019

Event ID: 81409

Reason for Recall:

After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.

Status: Terminated

Product Quantity: 108

Code Information:

Lot: 407483-1 and 407483-2

Distribution Pattern:

U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA

Voluntary or Mandated:

Voluntary: Firm initiated