Instrumentation Laboratory recalls ACL Elite analyzers that no longer support HemosIL Liquid Anti-Xa tests due to test definition removal. Affected units may require specific action.
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 analyzers that no longer support HemosIL Liquid Anti-Xa tests. This could lead to inaccurate coagulation test results if the analyzer is used without the correct test definition.
The analyzer removes the test definition for Hemos:IL Liquid Anti-Xa, which is critical for accurate coagulation testing. Without this definition, the device may produce incorrect results when running these specific tests.
Hemostasis lab technicians and clinical staff who use ACL Elite analyzers for coagulation testing. Those using the affected units without the proper test definition are at risk of inaccurate results.
Check for part number 0000880311 or UDI 08426950453017 on the device. Affected units have serial numbers starting with 23012282 or earlier.
Confirm if the analyzer has the HemosIL Liquid Anti-Xa test definition enabled for accurate coagulation testing.
The ACL Elite analyzer removes the test definition for HemosIL Liquid Anti-Xa, which is necessary for accurate coagulation testing.
The official recall notice does not specify a remedy or action steps for affected units.
Check for part number 0000880311 or UDI 08426950453017. Affected units have serial numbers starting with 23012282 or earlier.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1304-2023 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1304-2023 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.
