The Recall Desk

Manufacturer

Sekisui Diagnostics Llc

4 recalls in our database name Sekisui Diagnostics Llc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2013-10-23

Of the 4 recalls from Sekisui Diagnostics Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • HighFDA (Devices)·Z-0015-2014·2013-10-23

    OSOM C. Difficile Toxin A/B Test Kit Recalled for False Negative Risk

    Sekisui Diagnostics is recalling specific lots of the OSOM C. Difficile Toxin A/B Test Kit due to the potential for false negative results.

    Product
    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0463-2013·2012-12-12

    Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values

    Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which reduces the standard curve slope.

    Product
    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2012·2012-09-26

    Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values

    Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which may require more frequent sample dilutions.

    Product
    Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2012·2012-07-04

    Sekisui Recalls 1,600 Acetaminophen Assay Kits Due to Reagent Discoloration

    Sekisui Diagnostics is recalling 1,600 MULTIGENT Acetaminophen assay kits distributed in Illinois because discoloration of the enzyme reagent causes erratic test results.

    Product
    MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state