Use cautionMedical device recall · FDA · Published July 21, 2021
Beckman Coulter DxA 5000 Recall: Risk of sample contamination and infection
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).
Take action
Contact the company
📍Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
“Beckman Coulter DxA 5000 Recall: Risk of sample contamination and infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62177-beckman-coulter-dxa-5000-recall-risk-of-sample-contamination-and. Based on FDA recall #Z-2602-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2602-2021%22&limit=1).
The FDA announced on July 21, 2021, that Beckman Coulter Inc. is recalling DxA 500 automated sampling systems due to a potential for sample discharge. This defect could delay patient treatment and cause biohazard exposure. The agency classified the recall as Class II.
Distribution: US Nationwide in AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV
The hazard
According to the FDA, sample carriers may transport samples to an outer lane lacking a physical barrier, causing samples to drop. This could result in delays in providing appropriate medical treatment and substantial discharge of biohazardous material. The agency noted this risk includes infection with human transmissible blood-borne pathogens such as HBV, HCV, or HIV.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since June 20, 2017. Other recent recalls of similar products include DxC 500 AU Clinical Chemistry Analyzers (Sept. 2, 2026), DxC 500i Modules with Software 1.5 (July 15, 2026), and MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026). Additional recent recalls include the Emit 2000 Quinidine Assay (July 13, 2026), DxC 700 AU (Jan. 30, 2026), and Medline Blood Culture Kit (Dec. 24, 2025).
How to tell if you have this one
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.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for serial numbers starting with T230000 on the device to confirm if it's affected.
Contact Manufacturer
Reach out to Beckman Coulter for guidance on next steps if you have an affected device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Illinois, Indiana, Kentucky, Michigan, Minnesota, Ohio, Pennsylvania, Texas, West Virginia.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2602-2021 (July 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2602-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.