[pending] REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652
Pending LLM rewrite. Source: FDA_DEVICE Z-2028-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
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.
- Category
- Medical Device — Devices
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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