The Binding Site Group, Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0604-2019)

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: November 6, 2018

Date Posted: December 19, 2018

Recall Number: Z-0604-2019

Event ID: 81421

Reason for Recall:

Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.

Status: Terminated

Product Quantity: 60

Code Information:

Lot 413849

Distribution Pattern:

U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,

Voluntary or Mandated:

Voluntary: Firm initiated