Recall Z-1306-2023 ยท KFF Assay, Heparin
Instrumentation Laboratory
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
| Date | Sep 30, 2024 (initiated Feb 3, 2023) |
| Status | Open, Classified |
| Reason | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| Root cause | Device Design |
| Action | Werfen issued UPDATED- URGENT MEDICAL DEVICE REMOVAL MANDATORY TEST LIBRARY UPGRADE to 02.05.00 ACL ELITE/ ELITE PRO HEMOSTASIS TESTING SYSTEMS dated 2/3/23. {This is a follow up to the original notification that advised your facility of the removal of HemosIL Liquid Anti-Xa assay (PN 0020302600/0020302601) on the ACL Elite/Elite Pro system.} Letter states reason for recall, and action to take: The 02.05.00 Mandatory Library release can be installed on ACL Elite/Elite Pro systems, currently running software version 04.00.00 or 03.01.04, with Library 02.03.00 or higher. Any ACL Elite/Elite Pro |
| Quantity | 1 unit US |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China, Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, Ind |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090209 | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS Instrumentation Laboratory CO, Jun 2, 2009 |