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Instrumentation Laboratory Co. recalls ROTEM ex-tem; US Part No: 503-05-US
Recalled September 18, 2019 · FDA recall Z-2485-2019 · Instrumentation Laboratory
Hazard
Prolonged clotting times · FDA Class II
Units
364 kits
Sold at
States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.
Description
Prolonged clotting times
Product
ROTEM ex-tem; US Part No: 503-05-US
Manufacturer(s)
Instrumentation Laboratory Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →