Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- for reduced on-board instrument stability from 7 to 5 days. This affects current and future lots of the heparin testing device.
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 means the device may not function properly after 5 days instead of 7, potentially leading to inaccurate test results.
The device's on-board stability has been reduced from 7 days to 5 days. This means the device may not function correctly after 5 days, potentially causing inaccurate heparin test results.
Healthcare professionals using the HemosIL Liquid Anti-Xa- device for heparin testing are affected. Those who rely on this device for accurate blood clotting tests are at the highest risk.
Check if you have the HemosIL Liquid Anti-Xa- device with part number 0020302600. It was sold with ACL TOP Family 50 Series and ACL Elite/Elite Pro models.
Verify the device's on-board stability has been reduced from 7 days to 5 days.
The device's on-board stability has been reduced from 7 days to 5 days, which could lead to inaccurate heparin test results.
The recall record does not specify a remedy, so no action is required beyond checking the device's stability.
The device is safe to use as long as it is within the 5-day stability period.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-0149-2022 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-0149-2022 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.
