REMISOL Advance UDI-DI code: 13700962601874 All Software Versions:… — Class II medical device recall Z-2028-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-07-02, distributed nationwide. Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Labora
| Recall number | Z-2028-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-04-08 |
| Classified | 2025-06-25 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BG, BR, CA, CH, CN, CZ, DE, DK, ES, FR, GB, GR, HK, IE, IN, IT, JP, KR, KW, LB, MA, MX, MY, NL, NO, NZ, PL, QA, RO, SA, SE, SG, SK, TR, TW, ZA |
| Quantity | 1,805 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 13700962601874 |
| Serial numbers | 00D91CCN4569, 01052EAN4066-1, 0108770B32BD, 010ED8BA1DB4, 013BFA4DE6E8, 01528E8E6202, 019FFD98021B, 02283E1N4457, 0282BDBDEB2B, 02AAABBA5A8C, 02D519494FBC, 02DE316N4609, 035BE35AC0A1, 03B1522N6334-1, 040BAA05DBFD, 050051EAB0D8, 0566EBF93FEF, 056B0B6N5225, 05B0F1112277, 061F6CB76A03, 0674D9FN4346, 0704854DF870, 073AC4D02D33-1, 08264271A085, 086629959E4F and 475 more |
Product
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing, archiving and restoration of patient results.
Reason for recall
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2028-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.