Instrumentation Laboratory Co. ROTEM ex-tem; US Part No: 503-05-US Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ROTEM ex-tem; US Part No: 503-05-US
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
Lot # 42255901 (United States)
Products Sold
Lot # 42255901 (United States)
Instrumentation Laboratory Co. is recalling ROTEM ex-tem; US Part No: 503-05-US due to Prolonged clotting times. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Prolonged clotting times
Recommended Action
Per FDA guidance
-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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, MI, WI
Page updated: Jan 10, 2026