CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report
ACL Elite- Analyzer designed specifically recalled
Instrumentation Laboratory is recalling ACL Elite- Analyzer designed specifically for clinical use in the hemostasis laboratory, 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-1304-2023
- 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- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
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
Is ACL Elite- Analyzer designed specifically for clinical use in the hemostasis laboratory recalled?
Yes. Instrumentation Laboratory recalled ACL Elite- Analyzer designed specifically for clinical use in the hemostasis laboratory on 3 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1304-2023.
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: 08426950453017 Serial Numbers 23012282 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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