Home / Recalls / The Binding Site Group, Ltd. / Z-1301-2018

Z-1301-2018 Class II Terminated

Recalled by The Binding Site Group, Ltd. — Birmingham, N/A

Recall Details

Product Type
Devices
Report Date
April 11, 2018
Initiation Date
March 9, 2018
Termination Date
June 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 kits distributed to the U.S.

Product Description

Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.

Reason for Recall

The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

Distribution Pattern

US Distribution was made to CA. There was no foreign/military/government distribution.

Code Information

Lot 407460, UDI 05051700017688

Other recalls by The Binding Site Group, Ltd.

  • Z-0274-2022 Class II — Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Hu (October 15, 2021)
  • Z-2030-2021 Class II — FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie (May 20, 2021)
  • Z-0943-2021 Class II — Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A (November 18, 2020)
  • Z-2071-2020 Class II — The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700 (April 9, 2020)
  • Z-1500-2020 Class II — Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Prod (November 6, 2019)
  • Z-2110-2020 Class II — Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: (October 7, 2019)
  • Z-1327-2020 Class II — OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 (July 29, 2019)
  • Z-1619-2020 Class II — C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)0 (April 25, 2019)
  • Z-0671-2020 Class II — Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein (February 19, 2019)
  • Z-0604-2019 Class II — Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of (November 6, 2018)