REMISOL Advance Medical Device Software Defect Affecting Reference Range Calculations
A software issue in REMISOL Advance may incorrectly process date-of-birth information from laboratory systems, causing incorrect reference range calculations and potentially auto-validating erroneous test result flags. The actual test results are not changed, but their evaluation may be affected.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a software defect in a medical device that processes patient test results and can cause incorrect reference range validation and auto-validation of erroneous flags. Although the source states no illnesses or injuries have been reported, the risk of harm to patients through incorrect test result validation is significant because affected results could be uploaded to LIS systems without proper verification, potentially affecting clinical decision-making.
Plain-English summary
Beckman Coulter Inc. is recalling REMISOL Advance (UDI-DI: 13700962601874) due to a software defect affecting affected software versions B92487, B92488, C24317, C28652, C37500, D04164, C44703, C57017, C69412, C69413, C73942, C73941, C88470, and C88471. The software may incorrectly process date-of-birth information received from laboratory information systems (LIS). When a date of birth is set to 01/01/1900 or left empty, the device may incorrectly identify a patient as a newborn.
This defect affects validation rule execution based on incorrect reference ranges. Although the actual test results are not altered and are accurately displayed by REMISOL Advance, the evaluation flagging of results may be affected. The software issue may lead to wrong reference range calculations and can result in erroneous flagged results being automatically validated and uploaded to the LIS.
Approximately 1,805 systems are affected worldwide and distributed throughout the United States and internationally in numerous countries. Healthcare facilities using REMISOL Advance should review their test result validations and consider verifying recent patient results flagged as validated by the device, particularly those for newborns or patients with birth dates set to 01/01/1900 or missing dates.
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…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 1,805
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
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