ROTEM ex-tem; US Part No: 503-05-US
FDA Recall Z-2485-2019 · Posted None
Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeJPA
Date Initiated2019-07-23
Date Terminated2020-04-27
Product Quantity364 kits
Reason for Recall
Prolonged clotting times
Firm Action
-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: [email protected]
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
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.