ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coag...
FDA Device Recall #Z-1304-2023 — Class II — February 3, 2023
Recall Summary
| Recall Number | Z-1304-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 3, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Instrumentation Laboratory |
| Location | Bedford, MA |
| Product Type | Devices |
| Quantity | 358 units US; 558 units OUS |
Product Description
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
Reason for Recall
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Distribution Pattern
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 / Code Information
UDI: 08426950453017 Serial Numbers 23012282 and Prior
Other Recalls from Instrumentation Laboratory
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1538-2026 | Class II | GEM Premier 5000; Part No. 00055430008. | Jan 20, 2026 |
| Z-1528-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407504. | Jan 20, 2026 |
| Z-1524-2026 | Class II | GEM Premier 5000 PAK, Part No. 00055360004. | Jan 20, 2026 |
| Z-1533-2026 | Class II | GEM Premier 5000; Part No. 00055415005. | Jan 20, 2026 |
| Z-1534-2026 | Class II | GEM Premier 5000; Part No. 00055415008. | Jan 20, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.