Home / Recalls / The Binding Site Group, Ltd. / Z-2030-2021

Z-2030-2021 Class II Terminated

Recalled by The Binding Site Group, Ltd. — Birmingham

FDA device recall Z-2030-2021 was initiated by The Binding Site Group, Ltd. on May 20, 2021 and is designated Class II. Reason for recall: The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. The recall status is terminated (terminated February 4, 2025).

Recall Details

Product Type
Devices
Report Date
July 14, 2021
Initiation Date
May 20, 2021
Termination Date
February 4, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

Reason for Recall

The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, United Kingdom, Argentina, Egypt, GUADELOUPE, HONG KONG, India, Iran, Israel, Korea, Lebanon, Malaysia, Morocco, Oman, Singapore, Taiwan, Tunisia, Vietnam.

Code Information

Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022

Other recalls by The Binding Site Group, Ltd.

  • Z-2362-2026 Class II — Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: (April 16, 2026)
  • Z-0274-2022 Class II — Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Hu (October 15, 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)

FDA data resources