FDA Device recall Z-2028-2025
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487 by Beckman Coulter, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2028-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-08 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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
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.
Identifiers
| code_info | Remisol Advance UDI-DI code: 13700962601874 All affected units that contain All Software Version: B92487; B92488; C243…Remisol Advance UDI-DI code: 13700962601874 All affected units that contain All Software Version: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 System Serial Numbers: U.S.: 17 32 70 92 104 106 123 128 135 136 146 156 157 169 170 171 172 172 180 181 185 185 195 199 202 210 222 231 236 242 249 256 258 264 267 274 277 279 281 282 282 283 285 289 299 305 317 325 326 331 335 335 338 340 347 348 356 367 368 381 386 387 396 397 425 435 463 472 477 480 482 484 484 491 495 499 502 506 511 521 546 559 563 567 592 610 617 622 777 38848 38867 38868 38875 40555 40559 40572 40576 41077 41081 41095 41097 41106 41643 41644 41782 41788 41792 49317 49322 49327 49333 49335 49336 49343 51109 51118 51121 51402 51404 51408 51863 51865 51866 52138 52597 52599 52613 52622 53264 53269 53278 54364 54369 54374 54375 54376 56385 446377 449030 456942 464044 464731 467748 505548 505564 4100037 4100045 4100047 4100048 4100056 4100084 54500038312 5450 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2028-2025%22
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