Open, Classified

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.

FDA Recall Z-2028-2025 · Posted 2025-06-25

Recall StatusOpen, Classified

Product CodeJQP

Date Initiated2025-04-08

Product Quantity1,805 systems

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.

Firm Action

On 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

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.