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 VERSION 1.2 VERSION 1.3 VERSION 1.5 VERSION 2.1 VERSION 1.1 VERSION 2.0 VERSION 1.8 VERSION 1.4 VERSION 2.2 VERSION 1.11 VERSION 1.6 VERSION 1.7 VERSION 1.9 VERSION 1.10 VERSION 2.3 |
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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