Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- for reduced on-board instrument stability from 7 to 5 days. Affected units may cause inaccurate heparin measurements.
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Instrumentation Laboratory is recalling Hemos: Liquid Anti-Xa- Automated chromogenic assay for heparin testing due to reduced on-board instrument stability. This could lead to inaccurate heparin measurements in medical tests.
The instrument stability has decreased from 7 days to 5 days, meaning the device may not function properly after this period. This could result in inaccurate heparin measurements, potentially affecting patient treatment decisions.
Healthcare facilities using the HemosIL Liquid Anti-Xa- assay for heparin testing are affected. Patients receiving heparin treatments through this system may be at risk of inaccurate results.
Check for the HemosIL Liquid Anti-Xa- product on ACL TOP Family 50 Series or ACL Elite/Elite Pro systems. All currently released lots and future lots are affected.
Identify if your HemosIL Liquid Anti-Xa- is on ACL TOP Family 50 Series or ACL Elite/Elite Pro systems.
The recall is for reduced instrument stability, which could lead to inaccurate heparin measurements, but it does not pose an immediate safety risk.
Check if your HemosIL Liquid Anti-Xa- is on ACL TOP Family 50 Series or ACL Elite/Elite Pro systems, as all currently released lots and future lots are affected.
The recall does not specify a remedy, so contact Instrumentation Laboratory for guidance.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-0151-2022 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-0151-2022 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.
