The Binding Site Group, Ltd.: Medical Device Recalls in 2020

According to to data from the FDA, there were 6 medical device recalls made by The Binding Site Group, Ltd. in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
• Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
• VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.
• 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.
• C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
• Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319