Home / Recalls / The Binding Site Group, Ltd. / Z-0553-2018

Z-0553-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
February 14, 2018
Initiation Date
January 4, 2018
Termination Date
June 9, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49 kits to the U.S. office (32 kits further distributed)

Product Description

Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings

Reason for Recall

The low and high controls for the product are returning results above the assigned values.

Distribution Pattern

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

Code Information

Lot #416595, Exp. 31/03/2018; UDI #05051700018319

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  • 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)