DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1233-2025.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1233-2025.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1233-2025.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
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Beckman Coulter Laboratory Systems (suzhou) Co., Ltd. Recall FAQ
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd. is the subject of a medical devices safety report: DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.. The notice was published on January 10, 2025 by the U.S. Food and Drug Administration (FDA). Approximately 56 units are potentially affected.