Instrumentation Laboratory recalls ACL Elite Pro analyzers that may have removed test definition for HemosIL Liquid Anti-Xa (PN 002: 0020302600 and 0020302601). Affected units require verification and 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 refurbished ACL Elite Pro analyzers that may have removed test definition for HemosIL Liquid Anti-Xa. This could lead to inaccurate coagulation test results if the analyzer is used without the correct test definition.
The analyzer may have removed the test definition for HemosIL Liquid Anti-Xa, which is critical for accurate coagulation testing. Without this definition, the analyzer might produce incorrect results for specific blood tests.
Healthcare professionals using the ACL Elite Pro analyzers for coagulation testing are most at risk. Patients receiving inaccurate test results could be affected if the analyzer is not properly configured.
Check for part number 0001000311R and serial numbers starting with 16053360R or earlier. The product was sold as refurbished equipment for clinical use in hemostasis laboratories.
Check the part number (0001000311R) and serial number (starting with 16053360R or earlier) to confirm if the analyzer is affected.
The test definition for HemosIL Liquid Anti-Xa (part numbers 0020302600 and 0020302601) may be missing.
Check for part number 0001000311R and serial numbers starting with 16053360R or earlier.
The recall does not specify a remedy, so contact Instrumentation Laboratory for further instructions.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1307-2023 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1307-2023 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.
