Device product

ROTEM ex-tem; US Part No: 503-05-US

Z-2485-2019

July 23, 2019

Class II

Product summary

Firm: Instrumentation Laboratory Co.
Event: Event 83523
Status: Terminated
Classification: Class II
Quantity: 364 kits
Official record key: device-enforcement:Z-2485-2019

Official wording

Reason: Prolonged clotting times

Code information: Lot # 42255901 (United States)

Distribution pattern: 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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Prolonged clotting times