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AMS Diagnostics, LLC recalls AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Ac
Recalled April 2, 2014 · FDA recall Z-1268-2014 · AMS Diagnostics
Hazard
Marketing the devices outside 510(k) requirements · FDA Class II
Units
13 kits
Sold at
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Description
Marketing the devices outside 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.
Manufacturer(s)
AMS Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →