The Binding Site Group, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-1619-2020)
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:
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Product Classification:
Class II
Date Initiated: April 25, 2019
Date Posted: April 8, 2020
Recall Number: Z-1619-2020
Event ID: 84890
Reason for Recall:
A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
Status: Terminated
Product Quantity: 1 kit
Code Information:
Lot 455672
Distribution Pattern:
U.S.: FL
Voluntary or Mandated:
Voluntary: Firm initiated