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Devices
Device Recall AMS BUN UREA NITROGEN
Model / Serial
Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Product Description
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum || Quantitative determination of Bun in serum.
Manufacturer
AMS Diagnostics, LLC
1 Event
Recall of Device Recall AMS BUN UREA NITROGEN
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Manufacturer
AMS Diagnostics, LLC
Manufacturer Address
AMS Diagnostics, LLC, 1790 N Commerce Pkwy, Weston FL 33326-3204
Source
USFDA
Language
English
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