FDA-Device2013-04-17Class II
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Siemens Healthcare Diagnostics, Inc.
Hazard
Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
Sold states
Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Canada.
Affected count
13,083
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1073-2013Don't want to check this manually?
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