Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ROTEM extem (for use on ROTEM delta instrument)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ROTEM extem (for use on ROTEM delta instrument) see related information
Date Initiated by Firm July 23, 2019
Create Date September 06, 2019
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-2485-2019
Recall Event ID 83523
510(K)Number K101533  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product ROTEM ex-tem;
US Part No: 503-05-US
Code Information Lot # 42255901 (United States)
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact PBM Technical Support Center
800-678-0710
Manufacturer Reason
for Recall		 Prolonged clotting times
FDA Determined
Cause 2		 Nonconforming Material/Component
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: 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
Quantity in Commerce 364 kits
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = Tem Innovations GmbH
-
-