Instrumentation Laboratory recalls ACL Elite refurbished analyzers that no longer support HemosIL Liquid Anti-Xa tests. This affects hemostasis lab equipment used for coagulation testing.
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 analyzers that no longer have the test definition for HemosIL Liquid Anti-Xa. This means these analyzers can't properly run this specific coagulation test, which is critical for hemostasis lab work.
The recall involves the removal of the test definition for HemosIL Liquid Anti-Xa from the ACL Elite analyzers. This means the equipment can no longer properly run this specific coagulation test, which is essential for hemostasis laboratory work.
Hemostasis lab technicians and clinical staff who use the ACL Elite analyzers for coagulation testing. Those with the specific part numbers 0000880311R and UDI 08426:950965572 are most at risk.
Check for part number 0000880311R or UDI 08426950965572 on the analyzer. The serial number starts with 11121320R or earlier.
Verify your ACL Elite analyzer has part number 0000880311R or UDI 08426950965572.
The ACL Elite analyzers no longer have the test definition for HemosIL Liquid Anti-Xa, which is needed for specific coagulation testing.
Check if your analyzer has part number 0000880311R or UDI 08426950965572. If so, contact Instrumentation Laboratory for guidance.
The recall does not provide a fix; the remedy is null, meaning no action is required beyond checking if your analyzer is affected.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1306-2023 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1306-2023 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.
