Z-1304-2023Class II

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation...

Name: Z-1304-2023 ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation...
Creator: Instrumentation Laboratory
Published: 2023-02-03
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2023-02-03 / Open, Classified / root cause: design

FDA source

Instrumentation Laboratory began a recall of ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311 on 2023-02-03. FDA classified it as Class II and gives the reason as "Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1304-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-03
Posted: 2024-09-30
Recalling firm: Instrumentation Laboratory Co.
Product: ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
Product code: KFF Assay, Heparin
Reason for recall: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Root cause tag: design
FDA 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 in commerce: 358 units US; 558 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.
Product codes and lots: UDI: 08426950453017 Serial Numbers 23012282 and Prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1304-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1304-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30
Z-1305-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30
Z-1306-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30
Z-1307-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30

Product code KFF

K090209Class IIHemosil Liquid Heparin, Heparin Calibrators and Lmw and Uf Heparin ControlsInstrumentation Laboratory CO / cleared 2009-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)