FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory: ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
- Recall number
- Z-1305-2023
- Recalling firm
- Instrumentation Laboratory
- Product
- ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
- Status
- Open, Classified
- Initiated
- 2023-02-03
- Posted
- 2024-09-30
- Terminated
- not on file
- 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 system running a Test Library prior to 02.03.00 will first require an upgrade to ACL Elite/Elite Pro software 04.00.00 or 03.01.04, with Test Library 02.03.00, before upgrading to Test Library 02.05.00. Your local Werfen representative will install the 02.05.00 Mandatory Test Library at your next scheduled preventative maintenance or service applications visit. If you have any questions or require further assistance, please contact your local representative, or for technical questions, contact Werfen Technical Support Center at 1-800-678-0710, Option # 1 (English), Option # 1 (ACL Hemostasis Products). As part of this same final corrective action phase, test parameters on the ACL TOP Family/ACL TOP Family 50 Series will be released in later Q2 2023, with reduced on-board instrument claims to 4 days. The updates to remove the assay from the ACL Elite/Elite Pro and reduce the on-board instrument stability claims for the ACL TOP Family/ACL TOP Family 50 Series to 4 days is consistent with the FDA clearance under Special 510(k) K213464
- Quantity
- 129 units US; 2686 units OUS
- 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, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico, Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.
- Lot, serial or model codes
- UDI: 08426950451570 Serial Number 23015246 and Prior
- 510(k) numbers
- ["K090209"]
- PMA numbers
- not on file
- Product code
- KFF
- Firm FEI
- 1217183
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28