Abbott recalls ARCHITECT c4000 Processing Module (List No. 02P24) due to potential incorrect test results if error codes aren't resolved before running tests. Affected units may need correction to ensure accurate diagnostic results.
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Abbott is recalling its ARCHITECT c4000 Processing Module (List No. 02P24) because it can produce incorrect test results if error codes aren't properly resolved before starting tests. This affects laboratory equipment used for in vitro diagnostics, where accurate results are critical for patient care.
The processing module can generate incorrect test results if error codes aren't resolved before transitioning to the Running status. This happens because the system's fluid sense/pressure monitoring may not catch errors properly during the test process.
Laboratories using Abbott's ARCHITECT c4000 Processing Module for in vitro diagnostic testing are likely affected. Users who don't resolve error codes before running tests may get inaccurate results.
Check for the product name 'Abbott ARCHITECT c4000 Processing Module' with List No. 02P24. All units are affected, but the specific serial numbers aren't listed in the recall notice.
Ensure error codes are resolved before starting tests to prevent incorrect results.
Yes, if your lab uses the Abbott ARCHITECT c4000 Processing Module with List No. 02P24, you may get incorrect test results if error codes aren't resolved before running tests.
All units of the Abbott ARCHITECT c4000 Processing Module with List No. 02P24 are affected, but specific serial numbers aren't listed in the recall notice.
Ensure error codes are resolved before starting tests to prevent incorrect results. No return or replacement is required per the 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-1102-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1102-2019 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.
