Beckman Coulter recalls DxA 5000 devices with specific serial numbers due to potential sample contamination and infection risks. Affected units may cause delays in medical treatment and blood-borne pathogen exposure.
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).
Beckman Coulter is recalling DxA 5000 devices that could cause samples to drop out of the system, leading to delayed patient treatment and potential infection with blood-borne pathogens like HIV or hepatitis. This recall affects specific serial numbers.
The device's sample carriers may transport samples to an outer lane without a physical barrier. This can cause samples to drop, delaying patient treatment and potentially exposing users to blood-borne pathogens like HIV, hepatitis B, or hepatitis C.
Healthcare professionals using the DxA 5000 for in vitro diagnostics in the US are most at risk. Patients receiving lab tests with these devices could face delayed treatment or infection.
Check for serial numbers starting with T230000 (e.g., T23000077) on the device. The product is labeled as 'For in Vitro Diagnostic Use' and has reference numbers B87352 with B57634.
Look for serial numbers starting with T230000 on the device to confirm if it's affected.
Reach out to Beckman Coulter for guidance on next steps if you have an affected device.
The device may transport samples to an outer lane without a physical barrier, causing samples to drop and potentially delaying patient treatment or leading to infection with blood-borne pathogens like HIV, hepatitis B, or hepatitis C.
Affected serial numbers start with T230000 (e.g., T23000077, T23000075, etc.) as listed in the recall notice.
The recall does not require immediate stop use; however, affected users should check their serial numbers and contact Beckman Coulter for guidance.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2602-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2602-2021 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.
