Abbott recalls ARCHITECT c8000 Processing Module (List No. 01G06) 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 c8000 Processing Module (List No. 01G06) because it can produce incorrect test results if certain error codes aren't resolved before starting tests. This could lead to inaccurate medical diagnoses if the device is used without proper error handling.
The device may generate incorrect test results if specific error codes aren't resolved before transitioning to the Running status. This happens because the system's fluid sense/pressure monitoring system isn't fully functional when error codes persist, leading to inaccurate diagnostic data.
Healthcare facilities using the Abbott ARCHITECT c8000 Processing Module for in vitro diagnostic testing are most likely affected. Patients relying on accurate test results from this system could be impacted if errors go uncorrected.
The recalled product is the Abbott ARCHITECT c8000 Processing Module with List No. 01G06. All units with this specific list number are affected, as the recall covers all serial numbers.
Review the instrument for any error codes that need resolution before starting tests.
Yes, if the device is used without resolving error codes before running tests, it could produce incorrect results.
The affected device has List No. 01G06 for the ARCHITECT c8000 Processing Module. All units with this list number are included in the recall.
No, but you must resolve any error codes before starting tests to avoid incorrect results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1103-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1103-2019 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.
