Instrumentation Laboratory recalls Hemos: reduced on-board instrument stability from 7 to 5 days for liquid anti-Xa assays used in clinical labs. Affected lots may cause inaccurate test results.
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 HemosIL Liquid Anti-Xa- automated assays for clinical labs because the instrument stability has decreased from 7 days to 5 days. This could lead to inaccurate test results if the device is not properly maintained.
The device's on-board stability has been reduced from 7 days to 5 days. This means the instrument may not function correctly after this period, potentially causing inaccurate test results if not properly maintained.
Laboratory professionals using HemosIL Liquid Anti-Xa- assays in clinical settings. Those who rely on the device for accurate blood tests may be at risk of inaccurate results.
Check for the Part Number 0020302602 on the HemosIL Liquid Anti-Xa- assay. All currently released lots and future lots are affected.
Verify the on-board instrument stability period for your device. If it's less than 5 days, it may be affected.
The on-board instrument stability has been reduced from 7 days to 5 days, which could lead to inaccurate test results if the device is not properly maintained.
The part number is 0020302602.
All currently released lots and future lots are 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-0150-2022 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-0150-2022 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.
