Fetalscreen II
Brand(s)
Last updated
Summary
Product
Fetalscreen II
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 |
|---|---|---|
| Fetalscreen II | V273985 | Z488 |
Issue
A customer complaint investigation has confirmed that the lot of Fetalscreen II stated above shows unexpected macroscopic reactivity (agglutination) when performing QC testing with the positive control cells. This will impact the reading of rosettes to validate the positive control and may impact the reading of positive tests, potentially resulting in false negative results.
Recall Start Date: July 22, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Alba Bioscience Limited
James Hamilton Way, Penicuik, Scotland, Great Britain, EH26 OBF
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75924
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