DxC AU recallZ-1233-2025 · Beckman Coulter Laboratory Systems (Suzhou) CO., Ltd. · initiated Jan 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Laboratory Systems (Suzhou) CO., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software change control
What the company is doing
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
Recall details
- Recall number
- Z-1233-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 10, 2025
- Posted by the FDA
- Feb 25, 2025
- Recalling firm
- Beckman Coulter Laboratory Systems (Suzhou) CO., Ltd.
- Quantity
- 56
- Product code
- JJE
- FDA submissions
- K220977
- 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 description
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DxC AU C63520Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use8 recalls17 reports
- DxC AU C63519Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use6 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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