Abbott recalls specific models of Architect analyzers due to software issues in version 9.41 and earlier that may cause inaccurate test results for cardiac, metabolic, and other analytes. Affected units include c4000 REF 02P24-01/2P24, 1P86, 1R24, 1R25, c8000 REF 01G06-11/1G06, and c16000 REF units. No immediate action is required as the issue may not affect all users.
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 versions of their Architect c4000, c8000, and c16000 laboratory analyzers due to software issues in version 9.41 and earlier. These issues could lead to inaccurate test results for various medical analytes, including cardiac, metabolic, and toxicology tests. The recall does not require immediate action as the problem may not affect all users.
The software issues in version 9.41 and earlier can bypass error codes, cause incorrect calibration, and lead to inaccurate test results. This may result in incorrect measurements for cardiac, metabolic, toxicology, and other analytes, but the risk is not severe in typical laboratory use.
Healthcare facilities using the affected Architect analyzers for laboratory testing. The risk is low as the software issues may not cause serious harm in normal use.
Check if your Architect analyzer has a software version of 9.41 or earlier. Affected models include c4000 REF 02P24-01/2P24, 1P86, 1R24, 1R25; c8000 REF 01G06-11/1G06; and c16000 REF units. Serial numbers listed in the recall include C400000 through C402000 and beyond.
Verify your Architect analyzer's software version. If it is 9.41 or earlier, it may be affected.
No, the recall does not require immediate action. The software issues may not affect all users, so no action is needed unless your software version is 9.41 or earlier.
Tests for cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes may be affected.
Check your software version. If it is 9.41 or earlier, and your analyzer is one of the affected models (c4000 REF 02P24-01/2P24, 1P86, 1R24, 1R25; c8000 REF 01G06-11/1G06; c16000 REF), it may be affected.
We’ve drafted a message you can send Abbott Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0272-2022 — Abbott Laboratories Abbott Laboratories Hello, I own a Abbott Laboratories that is covered by recall Z-0272-2022 from Abbott Laboratories. 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.
