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AMS Diagnostics Recalls
4 recalls on record · April 2, 2014 to July 19, 2017 · Medical Devices
Recalls by year
14
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 19, 2017Medical DevicesFDA
AMS Diagnostics, LLC recalls Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Modu
Hazard: Lot was not functioning properly and not exhibiting the correct physical properties.
April 2, 2014Medical DevicesFDA
AMS Diagnostics, LLC recalls AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Hazard: Marketing the devices outside 510(k) requirements
April 2, 2014Medical DevicesFDA
AMS Diagnostics, LLC recalls AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Ac
Hazard: Marketing the devices outside 510(k) requirements
April 2, 2014Medical DevicesFDA
AMS Diagnostics, LLC recalls AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determinatio
Hazard: Marketing the devices outside 510(k) requirements