REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487
Medical device recall Z-2028-2025. Published in FDA’s Enforcement Report on Jul 2, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 2, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 51 states named
- 1,805 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1,805 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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.:…
Every code shown here, 2,000 characters
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 2B19759202DB 2CFE653187AA 2D1112FN6360-1 2DFA5950D842 2FEA4D3946D9 33CF743BB82D 36506847DDFB 36B26F88FC49 3739BEEN4664-14 3739BEEN4664-20 3739BEEN4664-3 3739BEEN4664-4 376B 378C831AD733 3BBC6B6BD0EE 3KMQ3N2 407EE1621977G 414A346N4299 450DE8A7B1B2 4577442F4D63 46D15B2N5053M 4775BC2CE283 47CD2A805D75 47US 48FC0D6A8500 4B70DD39A14B 4C94FD69755D 4EAC235N5841 4F282F3N4763 4MM0VH3 530CC57N4490 536FE83A386A 5C75FB377086 5DE93E442CAD 5E17E7876E63 5E73EB0BE391 5H5LT4J 60B94D992B0F 62EDE345CFD3 63347DCF82C2…
FDA’s list runs to 14,782 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, 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
The states and territories these words name
51 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 8, 2025.
- FDA classified it on Jun 25, 2025.
- FDA’s Enforcement Report published it on Jul 2, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter Inc., of Brea, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 14,782 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.