Recall MonitorHealth Products
REMISOL Advance
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: REMISOL Advance
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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