Recall archive / FDA device enforcement
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibri... — FDA record Z-1304-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 3, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
- Reason
- Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
- Classification
- Class II
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 358 units US; 558 units OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1304-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 08426950453017 Serial Numbers 23012282 and Prior |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Feb 3, 2023
- Center classification date
- Mar 30, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.