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Sekisui Diagnostics Recalls
4 recalls on record · July 4, 2012 to October 23, 2013 · Medical Devices
Recalls by year
12
13
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 23, 2013Medical DevicesFDA
Sekisui Diagnostics LLC recalls Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The
Hazard: Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.
December 12, 2012Medical DevicesFDA
Sekisui Diagnostics Llc recalls Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activa
Hazard: Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
September 26, 2012Medical DevicesFDA
Sekisui Diagnostics Llc recalls Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1
Hazard: SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
July 4, 2012Medical DevicesFDA
Sekisui Diagnostics Llc recalls MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative dete
Hazard: Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.