Abbott recalls ARCHITECT c16000 Processing Module (List No. 03L77) due to potential for incorrect test results if error codes aren't resolved before running tests. Affected units may need correction to avoid inaccurate 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 c16000 Processing Module (List No. 03L77) because it can cause incorrect test results if error codes aren't resolved before starting tests. This affects laboratory equipment used for in vitro diagnostics, where accurate results are critical for patient care.
The processing module may 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 system can't detect errors properly during the transition process.
Healthcare labs using the Abbott ARCHITECT System for in vitro diagnostics are most affected. Patients relying on accurate test results from this equipment could be impacted if errors occur.
The recalled product is the Abbott ARCHITECT c16000 Processing Module with List No. 03L77. All units with this specific list number are affected, as stated in the recall notice.
Ensure error codes are resolved before starting tests to prevent incorrect results.
No, this recall is low risk. The hazard involves potential for incorrect test results if error codes aren't resolved, but it doesn't cause physical harm or serious injury.
Your unit is affected if it has the Abbott ARCHITECT c16000 Processing Module with List No. 03L77, as all units with this specific list number are recalled.
Ensure error codes are resolved before starting tests to prevent incorrect results. The recall does not require immediate removal or replacement.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1104-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1104-2019 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.
