REMISOL Advance
Brand(s)
Last updated
Summary
Product
REMISOL Advance
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
REMISOL Advance |
All lots. |
VERSION 1.12 |
Issue
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:
- If the LIS sends 01/01/1900 as the DOB, REMISOL Advance using the ASTM host driver incorrectly interprets the age as 0 days.
- If the LIS sends an empty DOB, REMISOL Advance using the HL7 host driver incorrectly interprets the age as 0 days.
Recall start date: April 7, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Normand - Info Sasu
7 Rue Frederic Degeorge, Arras Cedex, France, 62028
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77344
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