CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report
Acl Elite Pro-Analyzer designed specifically recalled
Instrumentation Laboratory is recalling Acl Elite Pro-Analyzer designed specifically for clinical use in the hemostasis, distributed nationwide in the US. The recall was initiated on 3 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1305-2023
- FDA event ID
- 91748
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Feb 2023
- FDA classified
- 30 Mar 2023
- Reported
- 5 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Feb 2023 | Recall initiated by company | |
| 30 Mar 2023 | Classified by FDA | +55 days |
| 5 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Product as listed by the FDA
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Which lots are affected?
UDI: 08426950451570 Serial Number 23015246 and Prior
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 91748This product is part of a recall event; the main page for the event is ACL Elite Refurbished-Analyzer designed specifically recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ACL Elite Refurbished-Analyzer designed specifically recalled | Instrumentation Laboratory | Other | Nationwide | |
| CLASS II | ACL Elite- Analyzer designed specifically recalled | Instrumentation Laboratory | Other | Nationwide | |
| CLASS II | ACL Elite PRO Refurbished)-Analyzer designed specifically recalled | Instrumentation Laboratory | Other | Nationwide |
More recalls from Instrumentation Laboratory
All 77| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The GEM Premier 7000 with iQM3 is a portable critical care recalled | Instrumentation Laboratory | Device Malfunction | Nationwide |
| Device | CLASS II | GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory | Instrumentation Laboratory | Device Malfunction | Nationwide |
| Device | CLASS II | GEM Premier recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS II | GEM Premier 5000 with IQM2 recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS II | GEM Premier 7000 with iQM3 recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |