Beckman Coulter recalls AQUIOS CL Flow Cytometer System (Catalog #B30166) due to potential for incorrect test results from misidentified samples. Affected units may need correction.
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.
Beckman Coulter is recalling its AQUIOS CL Flow Cytometer System (Catalog #B30166) because it can process the same sample with two different sample IDs, leading to incorrect test results. This could cause misleading health information for users.
The device may process the same sample using two different sample IDs and sample information through its single tube loader. This mis-identification can cause erroneous test results, potentially leading to incorrect health conclusions.
Users of the AQUIOS CL Flow Cytometer System for laboratory testing are affected. Those performing medical or research tests with this device are most at risk of incorrect results.
Check for the AQUIOS CL Flow Cytometer System with Catalog #B30166. The device label shows 'Beckman Coulter Ireland, Inc.' in Co. Clare, Ireland. All software versions are affected.
Look for the label that states 'Beckman Coulter Ireland, Inc.' in Co. Clare, Ireland.
Confirm the software version matches the affected units described in the recall.
The recall is for potential incorrect test results, not an immediate safety hazard. The risk is low as it does not cause physical injury.
Check for the AQUIOS CL Flow Cytometer System with Catalog #B30166 and the label showing 'Beckman Coulter Ireland, Inc.' in Co. Clare, Ireland.
The recall does not specify a remedy, so no action is required beyond checking if your device matches the description.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1341-2018 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1341-2018 from Beckman Coulter. 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.
