FDA-Device2016-11-02Class II
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
TEM Systems Inc
Hazard
Customers complained of low/empty reagent vials.
Sold states
Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.
Affected count
637 boxes x 10 vials
Manufactured in
3210 E Nc Hwy 54, Durham, NC, United States
Products
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0302-2017Don't want to check this manually?
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