Home / Recalls / The Binding Site Group, Ltd. / Z-2071-2020

Z-2071-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 27, 2020
Initiation Date
April 9, 2020
Termination Date
August 19, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36

Product Description

The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

Reason for Recall

A software issue that may affect the analyzer's result accuracy.

Distribution Pattern

US Nationwide distribution including in the states of AL, AR, CA, FL, IL, IN, KS, KY, MA, MN, NC, NE, OH, PA, TX and VA.

Code Information

Analyzers running with software version 7.0 or 7.01

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-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)