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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Recall Number Z-1267-2014
Classification Class II
Code Info Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.
Product Distributed Qty 167 kits
Reason For Recall Marketing the devices outside 510(k) requirements

Event Detail

Event Id 67599
Product Type Devices
Status Ongoing
Recalling Firm AMS Diagnostics, LLC
City Weston
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
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