FDA-Device2014-07-09Class II
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Siemens Healthcare Diagnostics, Inc
Hazard
The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Sold states
Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentina, Austria, Australia. Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Libya, Macedonia, Malaysia, ,Malta, Martinique, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Republic of Korea, Romania, Russian Federation, Serbia, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Vietnam.
Affected count
34,283 kits
Manufactured in
333 Coney St, East Walpole, MA, United States
Products
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1991-2014Don't want to check this manually?
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