AMS Diagnostics, LLC

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2725-2017Class IIIMedica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; FFebruary 29, 2016
Z-1267-2014Class IIAMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum QuantFebruary 11, 2014
Z-1268-2014Class IIAMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative deteFebruary 11, 2014
Z-1269-2014Class IIAMS AST For the In vitro quantitative determination of AST in serum Quantitative determination oFebruary 11, 2014