Flowpra Class I And II Screening Tests
Brand(s)
Summary
Instructions provided on response.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Flowpra Class I And II Screening Tests |
Lot and Batch # 024.0000786207 |
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
| One Lambda Inc |
| 22801 Roscoe Blvd, West Hills, California, United States, 91304 |
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