DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. · Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assay…
Open FDA's page for this record- Cfres ID
- 212289
- Product res number
- Z-1233-2025
- Event date initiated
- 2025-01-10
- Event date posted
- 2025-02-25
- Recall status
- Open, Classified
- Res event number
- 96193
- Product code
- JJE
- Product description
- DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
- Firm FEI number
- 3027977508
- Recalling firm
- BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
- Address 1
- No. 11 Shengpu Street Zhensheng Road
- City
- Suzhou
- State
- Pingjiang
- Country
- China
- Additional info contact
- Courtney Walton 952-448-4848
- Root cause description
- Software change control
- Product quantity
- 56
- Code info
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
- 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
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
- Distribution pattern
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
- K numbers
- K220977
- Harmonized identifiers (openFDA)
- Device name
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.2160
- Device class
- 1
- K number
- K831649, K840868, K130915, K130276, K882450, K832115, K912844, K922072, K903071, K811919, K881495, K862818, K822465, K860080, K002982, K833448, K843059, K933703, K940810, K842500, K923060, K760642, K810596, K810129, K833833, K921661, K133519, K782014, K840501, K922220, K885226, K862235, K971761, K811194, K901346, K920402, K902336, K950958, K003721, K872494 +168 more
- PMA number
- P910007
- Registration number
- 9610942, 3005748564, 3005655287, 3010421384, 2026994, 3024082778, 3023162659, 3002642396, 2250051, 3008494306, 9610566, 3029973107, 3000148879, 3003589956, 3004529019, 3006198300, 9614373, 3004973408, 8020888, 9615754, 9680746, 3009518015, 3048199746, 3002809144, 9615837, 3017548799, 3008853996, 3012526002, 3016244760, 3017894300, 1319436, 3005094123, 3039396083, 3003593973, 3027977508, 1319808, 3002895169, 3007111389, 3005333358, 3014717638 +139 more
- FEI number
- 3004445302, 3005748564, 1000305840, 3005655287, 3010421384, 2026994, 3024082778, 3002485711, 3023162659, 3002642396, 2250051, 3008494306, 3029973107, 3000148879, 3003589956, 3004529019, 3002806809, 3006198300, 3004973408, 1000119795, 3009518015, 3048199746, 3002809144, 3002807663, 3017548799, 3008853996, 3012526002, 3016244760, 3017894300, 3002808382, 3005094123, 3002808340, 3002608770, 3039396083, 3003593973, 3027977508, 3002895169, 3007111389, 3005333358, 3014717638 +139 more