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TEM Systems Inc recalls ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation
Recalled November 2, 2016 · FDA recall Z-0302-2017 · TEM Systems
Hazard
Customers complained of low/empty reagent vials. · FDA Class II
Units
637 boxes x 10 vials
Sold at
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.
Description
Customers complained of low/empty reagent vials.
Product
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.
Manufacturer(s)
TEM Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →