Instrumentation Laboratory recalls ACL Elite Pro analyzers that no longer support HemosIL Liquid Anti-Xa tests (part numbers 0020302600/002:0302601). Affected units may cause inaccurate coagulation test results.
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Instrumentation Laboratory is recalling ACL Elite Pro analyzers that no longer support HemosIL Liquid Anti-Xa tests. This could lead to inaccurate coagulation test results if users try to run these tests on the affected equipment.
The recall involves the removal of test definition for HemosIL Liquid Anti-Xa from the ACL Elite Pro instruments. This means the analyzers may not properly process these tests, potentially causing inaccurate coagulation results.
Healthcare professionals using ACL Elite Pro analyzers for coagulation testing may be affected. Those who use the specific HemosIL Liquid Anti-Xa tests with these analyzers are most at risk.
Check for part numbers 0020302600 or 0020302601 on the HemosIL Liquid Anti-Xa tests. The affected analyzers are used in hemostasis laboratories for coagulation testing.
Verify if your HemosIL Liquid Anti-Xa tests (part numbers 0020302600 or 0020302601) are compatible with your ACL Elite Pro analyzer.
The ACL Elite Pro analyzers no longer support the HemosIL Liquid Anti-Xa tests due to the removal of test definition.
Check if your HemosIL Liquid Anti-Xa tests (part numbers 0020302600 or 0020302601) are compatible with your ACL Elite Pro analyzer.
The recall does not pose a safety risk but may result in inaccurate coagulation test results if the tests are used on affected analyzers.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1305-2023 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1305-2023 from Instrumentation Laboratory. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
