Home / Recalls / The Binding Site Group, Ltd. / Z-0604-2019

Z-0604-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
December 19, 2018
Initiation Date
November 6, 2018
Termination Date
April 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60

Product Description

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

Reason for Recall

Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.

Distribution Pattern

U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,

Code Information

Lot 413849

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