Abbott recalls ARCHITECT c160:00 cuvette segments that may cause false low test results. Affected units have specific part numbers and serial numbers. Consumers should contact Abbott for details.
There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
Abbott is recalling cuvette segments for their ARCHITECT Clinical Chemistry system that could cause false low test results. This means some lab tests might show incorrect results if the faulty segments are used.
The cuvette segments can detach during use, causing tests to show falsely low results. This happens when the segments are used with c4000, c8000, or c16000 instruments. The issue does not cause physical harm but affects test accuracy.
Lab users with the ARCHITECT c16000 system who have the specific cuvette segments (part #09D32-05/03L77) are affected. The risk is low as it only affects test results, not safety.
Check for part number 09D32-05/03L77 on the cuvette segments. The segments are sold with the ARCHITECT Clinical Chemistry system and come in sets of 15 segments holding 330 cuvettes.
Look for part number 09D32-05/03L77 on the cuvette segments to confirm if they are affected.
Using the recalled segments may cause false low test results in some lab tests, but it does not cause physical harm.
Check for part number 09D32-05/03L77 on the cuvette segments. The segments are sold with the ARCHITECT Clinical Chemistry system.
No, the recall does not require immediate stop use. Affected users should check the part number and contact Abbott for further instructions.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0923-2018 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0923-2018 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.
