Flowpra Class I And II Screening Tests
Brand(s)
Last updated
Summary
Product
Flowpra Class I And II Screening Tests
Issue
Medical devices - Performance
What to do
Instructions provided on response.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Flowpra Class I And II Screening Tests | Lot and Batch # 024.0000786207 Lot and Batch # 024.0000791526 Lot and Batch # 024.0000813195 Lot and Batch # 024.0000806730 Lot and Batch # 024.0000798137 | FL12-60 |
Issue
A suspected false negative for HLA class I with FL1-30 lot 022. Complaint investigation testing was performed using 4 samples with low levels of A2 antibody specificities and 1 sample with low levels of A31 antibody specificities. Investigation confirmed a lower percentage of positive reactions for samples tested with FL1-30 lot 022. In addition, investigation noted that lot specific user document, TDX-OLI-DMR-LOT-8536 revision 01, has incorrect reference values for the distribution of certain HLA class I antigen specificities.
Recall start date: May 29, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
| One Lambda Inc |
| 22801 Roscoe Blvd, West Hills, California, United States, 91304 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75703
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