ACL ELITE recallZ-1304-2023 · Instrumentation Laboratory · initiated Feb 3, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Instrumentation Laboratory or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-1304-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 3, 2023
- Posted by the FDA
- Sep 30, 2024
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 358 units US; 558 units OUS
- Product code
- KFF
- FDA submissions
- K090209
- 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.
Product description
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
Code information (models, lots, serial numbers)
UDI: 08426950453017 Serial Numbers 23012282 and Prior
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACL ELITE 00000880311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K090209 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HemosIL Heparin Calibrators 00020300600Instrumentation Laboratory Company · CALIBRATOR, PRIMARY1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91748).
- Z-1305-2023 · Open, ClassifiedACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
- Z-1306-2023 · Open, ClassifiedACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
- Z-1307-2023 · Open, ClassifiedACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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