Home / Recalls / The Binding Site Group, Ltd. / Z-0274-2022

Z-0274-2022 Class II Terminated

Recalled by The Binding Site Group, Ltd. — Birmingham

Recall Details

Product Type
Devices
Report Date
December 1, 2021
Initiation Date
October 15, 2021
Termination Date
February 4, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,254 kits

Product Description

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

Reason for Recall

Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

Distribution Pattern

U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada

Code Information

Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664

Other recalls by The Binding Site Group, Ltd.

  • 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)
  • Z-1469-2020 Class II — VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in v (August 12, 2018)