🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: April 8, 2025 Beckman Coulter Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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 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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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beckman Coulter Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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 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B0BE1A64BF76 B19CBCDN4447 B1B51824E5AD B24E832N4312 B2C3ED0E41C4 B2D1FDEN6636-1 B372148N4658 B39F1CEN4818-1 B48F052024D5 B55941AC3033 B563703282CF B651KD3 B65CF94397 B6D8D612DF51 B6R0842 B7DA0696B41C B81FB22 B9330B6N6056-1 B9BC0F8BA5D9 BBA5A4DE3C27 BCH365J BD0DFE1N4379 BE4AEC15D60C BELIS-003 BELIS-005 BELIS-008 BELIS-010 BELIS-011 BELIS-022 BELIS-031 BELIS-039 BELIS-043 BELIS-044 BELIS-046 BELIS-047 BELIS-050 BELIS-051 BELIS-053 BELIS-054 BELIS-057 BELIS-058 BELIS-061 BELIS-062 BELIS-065 BELIS-068 BELIS-069 BELIS-070 BELIS-071 BELIS-072 BELIS-073 BELIS-074 BELIS-075 BELIS-076 BELIS-077 BELIS-078 BELIS-079 BELIS-080 BELIS-081 BELIS-082 BELIS-083 BELIS-084 BELIS-085 BELIS-086 BELIS-087 BELIS-088 BELIS-089 BELIS-090 BELIS-091 BELIS-900 BXGYP3J C008BBA3 C02509A9 C02AC5CE C02DC5CE C03C85A9 C04183A9 C060EEF6 C0750AD21F7C C09209A9 C09685F6 C098566C C0B1CAD3 C0B7CBDF C0D343513A48 C0DFEEF6 C0E4EEF6 C0EBEEF6 C0ED41AD C0FE4863 C10A0CD230BD C1A96971578E C2C3300H89 C2C3300H8C C34609CC37E6 C3825E6C32EA C424D77B8137 C42B1T2 C44B1T2 C4627B13E1B9 C47CC31F0FA0 C4DEE2DA8B06 C4N71T2 C4Q81T2 C51C2A29517F C570170003 C63QRH2 C640C64123A7 C64A1C5ED1CB C69413AA0007 C6D80320B798 C6F291DN5862 C73941AB0073 C73941AD0618 C78RNT3 C7BF7B2N4472 C88470AD0122 C9DFA6FN4790 CA02AF5N4537 CA43DAAAE0D5 CB276292A072 CC5E4E89C1E5 CC7BC17BDDAF CC7EFBC51492 CD9444J CD97F472B495 CDA935BADAB6 CDAD8ECF38B4 CE5375CN4250 CE86AC732417 CE8966AF872B CEE9911N4471 CEF7F95A3DC8 CZC32503KJ CZC3300H86 CZC3300H8F CZC3300H8P CZC5371W2M CZC5371WTB CZC5403065 CZC540306N CZC5403072 CZC540307V CZC540307Y CZC540307Z CZC540308G D0C20BAECD09 D0CRCM2 D0FPCM2 D0FRCM2 D0FTCM2 D15CD6FDFE86 D1D5804N4412 D22398AF8C16 D2F4E94N5858-1 D2K0107F00692 D2K0307F01043 D2K1105F00349 D2K1105F00350 D3DE2BEB334F D5DB912F4A3B D6A5AA44C283 D7F09DDA3981 D827FBABD6DA D862C8268ADB D9C63A544199 DB00079, 77466114-1 DB230044-77485263 DBCDB907FF92 DDE2DC5FF249 DE62D44B75B1 DE845A04888D DF0A13C1BB4F DF5A5D8E8A00 DF9444J DFC867EAA6E6 DFD8B58N5148 DG210023, 77469506 DG210029, 77469785 DJ50824 DJCBG5J DL0305FL00183 DL0805FL00277 DNE80079-77447756 DNW90093, 77456281 DS210012, 77468063 DS210017, 77468826 DS210025,77469595 DS210031, 77469978 DS210034, 77470125 DS210038, 77470724 DS210045, 77470862 DS80070-77447143 DS90045-77452638-1 DSW90101, 77457135 DXLABC-003 DXLABC-004 DXLABC-005 DXLABC-008 DXLABC-009 DXLABC-011 DXLABC-013 DXLABLIS-S_20221201 DXLABLIS-S_20230227 DXLABLIS-S_20230428 DXLABLIS-S_20230731 DXLABLIS-S_20231106 DxLab-Support_ i_20231120 DxLab-Support_ i_20240618 E1CDB12N5825-6 E2440A99D0BC E2843DAN4820 E30837F27384 E4A95DF3257A E4D6DE5BAC32 E54CFC5N4443 E569B22N4586 E57075C0A0F9 E57DC70D202A E5AC73F47925 E5B56C5CAC2D E612AF506BCB E757123N5414-10 E7888463A25C E7A0B2368DF0 E87879E1595E E92A4BD0AB95 EA060A6E494E EA509BDB9A21 EAA3600N4273 EE4A341N4628 EEB0C94B7B60 EF0F514F888C F04A84CEDB8C F1549DC6D46B F18561BB7C09 F1F4438F4215 F2A5F1C75791 F312420M2337 F312420M2337-1 F33859FD9085 F340AF60583A F39CEE0N6900-1 F6D8F625806E F70C293N4639 F73A2E2B198E F7B2C9BN4185 F7C879FN4979 F805B45N4720 F899722N6168-1 F974C41700A8 F9F6FF9N5968-1 FA5963DN5051 FAE85589BEF0 FB4396EAD3C1 FBADC12003C9 FC5F1426E05C FF4A0CF64BF6 FF60C5J FP3BST3 FR21114499 FR21516794 FR22617620 FR22617631 FRB4020NZ8 FRB4020P03 FRB4020P2P FRB4020P35 FRB4030RP7 FRB4030RRX FRB4030RS3 FRB403RPD FRB4040BQH FTF4D4J FW44DK2D FW7BDK2D GP3BST3 GR14G32D H16K1N3 H3FPZ4J HDJ0VH3 HDNGDD2 HDPGDD2 HKLZGQ2 HN201Q2 HN931Q2 HRFPZ4J HUB40400VJ HUB50400VQ HUB50400VX HUB50404G7 HUB50404GM HVSRH3J HY3X15J J15LSG2 J16FSG2 J19GSG2 JGM5Z3J JL9NLY3 JLZHLZ3 JP6Q83J JRFPZ4J K70112177 KN8Z66DD L14321708 N/A NL12119211 NL14012345 NL14124217 NL14513678 NL20412947 NL21227930 NL22414406 OLCOS-006 OLCOS-010 OLCOS-018 OLCOS-030 OLCOS-031 OLCOS-032 OLCOS-033 OLCOS-036 OLCOS-044 OLCOS-051 R21114482 R221111740 R22617632 R2K0706F00616 R2KADV 3312 R2KADV 3497 R2KADV#3402 R2KADV#3416 R2KADV#3571 R2KADV1027 R2KADV1116 R2KADV1144 R2KADV1152 R2KADV1315 R2KADV1316 R2KADV1429 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2028-2025

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