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AMS Diagnostics, LLC recalls AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determinatio
Recalled April 2, 2014 · FDA recall Z-1267-2014 · AMS Diagnostics
Hazard
Marketing the devices outside 510(k) requirements · FDA Class II
Units
167 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 BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Manufacturer(s)
AMS Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →