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AMS Diagnostics, LLC recalls AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Recalled April 2, 2014 · FDA recall Z-1269-2014 · AMS Diagnostics
Hazard
Marketing the devices outside 510(k) requirements · FDA Class II
Units
116 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 AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Manufacturer(s)
AMS Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →