Z-1233-2025Class II

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software

Name: Z-1233-2025 DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software
Creator: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Published: 2025-01-10
License: https://open.fda.gov/license/

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. / initiated 2025-01-10 / Open, Classified / root cause: software

FDA source

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. began a recall of DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software on 2025-01-10. FDA classified it as Class II and gives the reason as "Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1233-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-10
Posted: 2025-02-25
Recalling firm: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Product: DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Root cause tag: software
FDA root cause: Software change control
Action: On 1/10/2025, recall notices were mailed to customers who were asked to do the following: 1) Replace and discard any reagent bottles that were on-board the analyzer at the time of any software upgrade. 2) Review Quality Control data and actions taken, for shifts out of allowed laboratory range which could have indicated potential deterioration in reagent stability. 3) Firm recommends sharing the content of this letter with your laboratory and/or Medical Director to determine if a review of previous patient test results should be conducted. 4) If specific software upgrade date is required, contact firm. 5) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. This issue will not occur with future software updates. If you have any questions regarding this notice, please contact the firm's Customer Support Center: Website: http://www.beckmancoulter.com Hotline: (800) 854-3633
Quantity in commerce: 56
Distribution: US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR. OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of Korea
Product codes and lots: Software Versions: V1.4, V1.4.1, V1.4.2, V1.4.3 REF/UDI-DI/Serial Numbers: C63519/14987666545058/2024090170; C63520/14987666545065/2024070116, 2023070009, 2024010038, 2024010035, 2024050072, 2024040056, 2024030049, 2024020046, 2024070111, 2024030051, 2024030052, 2024010033, 2023090015, 2024060103, 2024060104, 2024060101, 2024080145, 2024020045, 2024020042, 2024020043, 2024020047, 2024060096, 2024040059, 2023100019, 2024030053, 2023070010, 2024070129, 2024070130, 2024020041, 2024090183, 2024010036, 2024010037, 2024070132, 2024070131, 2023100020, 2024050064, 2024050070, 2023090016, 2023110022, 2024070110, 2024060075, 2024060106, 2023110023, 2024010024, 2024010025, 2024050066, 2024010029, 2024060107, 2023080012, 2024040060, 2024050074, 2024040062, 2024010031, 2024030055, 2024080144

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-25

Product code JJE

K220977Class IIISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. / cleared 2023-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)