Abbott recalls ARCHITECT i1000SR, i2000SR, and i2000 analyzers with software version 9.41 and earlier due to software issues that may cause inaccurate test results for cardiac, metabolic, and other analytes.
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
Abbott is recalling specific models of their ARCHITECT i1000SR, i2000SR, and i2000 analyzers that have software version 9.41 or earlier. These devices may produce inaccurate test results for cardiac, metabolic, and other analytes due to software issues. Users should check if their device is affected and contact Abbott for guidance.
The software issues in version 9.41 and earlier can cause inaccurate test results for various analytes, including cardiac, metabolic, toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes. The problems may lead to incorrect results with an unknown bias direction and magnitude.
Healthcare facilities and labs that use Abbott's ARCHITECT i1000SR, i2000SR, or i2000 analyzers with software version 9.41 or earlier are most at risk. The recall affects specific serial numbers and model numbers listed in the official notice.
Check if your device has the model numbers ARCHITECT i1000SR, i2000SR, or i2000 with software version 9.41 or earlier. The recall includes specific serial numbers listed in the official notice.
Verify your device's software version by checking the device settings or documentation. If it is 9.41 or earlier, it is affected.
Reach out to Abbott Laboratories directly for instructions on how to update the software or replace the device if necessary.
Software versions 9.41 and earlier are affected.
Tests for cardiac, metabolic, toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, and inflammatory analytes may be inaccurate.
Check your device's serial number against the list of affected serial numbers provided in the official recall notice.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0271-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0271-2022 from Abbott. 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.
