DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
FDA device recall Z-1233-2025 · posted 2025-02-25 · Open, Classified
Recall details
- Recalling firm
- BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
- 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.
- Action taken
- 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
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- JJE
- Quantity affected
- 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
- Date initiated
- 2025-01-10
- Date posted
- 2025-02-25
- Location
- Suzhou, Pingjiang, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (K220977) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-07-20 |