Medical device software defect affecting laboratory result validation and reference ranges
REMISOL Advance laboratory data management system has a software bug that incorrectly identifies patients as newborns when date of birth is empty or set to 01/01/1900, potentially affecting result validation and reference range calculations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with software defect affecting patient age calculation and result validation logic. No illnesses or injuries have been reported, placing this in the risk-of-harm category where potential injury has not yet occurred.
Plain-English summary
REMISOL Advance is a laboratory data management system manufactured by Beckman Coulter Inc. The system collects and manages data and workflow for approximately 1,805 laboratory automation and information systems worldwide. It provides automatic results validation, delta checking, reflex testing, quality control, results editing, and archiving capabilities.
A software defect in the system's date of birth processing logic causes incorrect patient age identification. When a patient's date of birth is set to 01/01/1900 or left empty, REMISOL Advance incorrectly identifies the patient as a newborn. This triggers the application of validation rules based on newborn reference ranges instead of the patient's actual age.
The actual test results and their displayed values are not altered by this defect. However, the evaluation and flagging of results may be incorrect. Erroneous flagging can lead to results being auto-validated and uploaded to the Laboratory Information System with improper evaluation status, potentially affecting clinical interpretation and patient care decisions.
Health care facilities using affected REMISOL Advance systems should contact Beckman Coulter regarding a software update to correct the date of birth processing logic in their systems.
The recalled product
- Product
- 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 con
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- software-defect
- incorrect-patient-age-identification
- validation-error
- reference-range-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- B92488
- C24317
- C28652
- C37500
- D04164
- C44703
- C57017
- C69412
- C69413
- C73942
- C73941
- C88470
- 77469506 DG210029
- 77469785 DJ50824 DJCBG5J DL0305FL00183 DL0805FL00277 DNE80079-77447756 DNW90093
- 77456281 DS210012
- 77468063 DS210017
- 77468826 DS210025
- 77469595 DS210031
- 77469978 DS210034
- 77470125 DS210038
Distribution
Distributed nationwide across the United States.
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