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FDAFDA · Food and drugs·Recall number Z-0859-2015

ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.

Published December 31, 2014 · Recall initiated: October 9, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Siemens Healthcare Diagnostics, Inc.
Distributor
Nationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Lot
Product Codes: 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011 and 10361012
Risk classification
Class II
Area (FDA)
device
Country
United States

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