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U.S. Department of Health and Human Services

Class 2 Device Recall REMISOL Advance

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 Class 2 Device Recall REMISOL Advancesee related information
Date Initiated by FirmApril 08, 2025
Date PostedJune 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2028-2025
Recall Event ID 96685
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductREMISOL 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.
Code Information 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 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R2KADV1457 R2KADV1462 R2KADV1465 R2KADV1575 R2KADV1581 R2KADV1589 R2KADV1609 R2KADV1744 R2KADV1924 R2KADV1936 R2KADV1945 R2KADV1950 R2KADV2015 R2KADV2089 R2KADV2105 R2KADV2127 R2KADV2144 R2KADV2156 R2KADV2163 R2KADV2192 R2KADV2224 R2KADV2228 R2KADV2287 R2KADV2348 R2KADV2441 R2KADV2442 R2KADV2443 R2KADV2444 R2KADV2448 R2KADV2522 R2KADV2531 R2KADV2572 R2KADV2606 R2KADV2689 R2KADV2745 R2KADV2755 R2KADV2824 R2KADV2958 R2KADV3152 R2KADV3166 R2KADV3207 R2KADV3210 R2KADV3288 R2KADV3296 R2KADV3323 R2KADV3328 R2KADV3335 R2KADV3383 R2KADV3384 R2KADV3385 R2KADV3386 R2KADV3393 R2KADV3453 R2KADV3492 R2KADV3662 R2KADV3721 R2KADV3743 R2KADV3830 R2KADV3856 R2KADV3857 R2KADV4097 R2KADV4134 R2KADV4445 R2KADV4446 R2KADV4479 R2KADV4579 R2KADV519 R2KADV535 R2KADV724 R2KADV749 R2KADV790 R2KADV838 R2KADV840 R2KADV910 REM-ROYAL BROMP SL snb121 UNL20414254
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 04/07/2025, the firm sent via email, or postal mail an "Urgent Medical Device Recall" Letter to customers informing them that Beckman Coulter has identified an issue with REMISOL Advance when receiving a sample order from the Laboratory Information System (LIS) if the patient's Date of Birth (DoB) is not entered or is unknown. Customers are instructed to: . Verify that their system is configured with the default validation rules and ranges. REMISOL Advance will utilize these default validation rules in situations where the patient's age or date of birth is unknown (please see the chapter Reference and Validation Ranges 1-233 in the IFU) OR . Ensure that the DoB field is not left empty and confirm with their LIS vendor that they do not use 01/01/1900 as a default date of birth. If they do, request that this default date be changed to 02-Jan-1900 (02/01/1900) to allow REMISOL Advance to correctly estimate the patient's age. Beckman Coulter will: . The IFU will be revised to specify that the DoB is required for generating and validating results. . Beckman Coulter will provide software updates upon customer request. For HL7 Host Driver Users: . Beckman Coulter has implemented the correction in software versions = 2.3.09. For ASTM Host Driver Users: . Beckman Coulter will implement the correction in software version 2.4. For questions, contact Customer Support Center via http://www.beckmancoulter.com
Quantity in Commerce1,805 systems
DistributionWorldwide - U.S. Nationwide distribution including in the states of AK, AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Australia, Austria, Bangladesh, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Czechia, Denmark, Ethiopia, France, French Polynesia, Germany, Greece, Guam, Hong Kong, India, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Kyrgyzstan, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Turkey, Uganda, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, and Zimbabwe
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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