The Recall Desk

Manufacturer

AMS Diagnostics, LLC

4 recalls in our database name AMS Diagnostics, LLC as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2017-07-19

Of the 4 recalls from AMS 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

  • LowFDA (Devices)·Z-2725-2017·2017-07-19

    AMS Diagnostics Recalls Medica ISE Module Calibrant A Due to Physical Defects

    AMS Diagnostics is recalling 9 units of Medica ISE Module Calibrant A because the lot was not functioning properly and did not exhibit correct physical properties.

    Product
    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1268-2014·2014-04-02

    AMS Uric Acid Test Kits Recalled for Regulatory Violations

    AMS Diagnostics is recalling 13 Uric Acid test kits because they were marketed outside FDA 510(k) requirements.

    Product
    AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2014·2014-04-02

    AMS AST Diagnostic Kits Recalled for Marketing Outside 510(k) Requirements

    AMS Diagnostics is recalling 116 AMS AST kits because they were marketed outside FDA 510(k) requirements. The recall covers nationwide distribution.

    Product
    AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1267-2014·2014-04-02

    AMS BUN Urea Nitrogen Kits Recalled for Marketing Violations

    AMS Diagnostics is recalling 167 BUN Urea Nitrogen kits because they were marketed outside FDA 510(k) requirements.

    Product
    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide