Beckman Coulter Inc.: REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471

Hazard

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.

Details from the source

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. Distribution: Worldwide - 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, Ethiop Quantity: 1,805 systems Lot/code info: 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 54500067343 54500097106 4.97599E+11 01528E8E6202 035BE35AC0A1 0566EBF93FEF 05B0F1112277 08264271A085 08B2884CF34D 0A4F73351D46 0BAA9B3E6F79 0F6150CE298B 12287B7N6820-1 127EA00228 1485F9A15826 1578A1454DE6 15D6D7DN6368-1 15D6D7DN6368-10 15D6D7DN6368-14 15D6D7DN6368-20 15D6D7DN6368-31 15D6D7DN6368-36 15D6D7DN6368-80 15D6D7DN6368-85 1708ADA3E866 178E4290C258 19B49E634515 19BEDD5N6463-1 1P7275J 2338012427-1 2429818C82CD 24F7B00N4487 28E051DFA01B 28FA1B1N4758A 28FA1B1N4758E 2948MR2 2956MR2 2A5ABC8DF42C 2B1

UPC codes

13700962601874, 54500038312, 54500067343, 54500097106, 85470370501

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.