ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
This recall has been terminated (originally issued July 23, 2019).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- July 23, 2019
- Terminated
- April 27, 2020
- Recall Number
- Z-2487-2019
- Quantity
- 722 kits
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot # : 42255701
Root Cause
Nonconforming Material/Component
Action Taken
-Check your inventory for Lot No. 42255901 / 42255801 and destroy all remaining material. - Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to the fax number or e-mail address listed on the next page. -Contact your local representative for an alternative product lot of ROTEM ex-tem, Part No. 503-05-US / 503-05-CA. -Share this information with your laboratory staff and follow your internal procedures. -Forward this notification to all affected locations within your facility. -Retain a copy of this notification for your records. -Return the completed and signed form confirming lot destruction and quantities to: FAX No. 781-861-4207 or Email: ra-usa@ilww.com For Technical Questions: Call ROTEM PBM Technical Support Center at 1-800-678-0710, Option # 4 For Replacement Lot: Call IL Customer Service Center at 1-800-955-9525, Option # 0