FDA recall Z-2485-2019

Instrumentation Laboratory Co. · Class II · device

Product

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

Reason for recall

Prolonged clotting times

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2019-07-23
Report date: 2019-09-18
Termination date: 2020-04-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bedford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2485-2019