hCG One Step Pregnancy Tests
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
hCG One Step Pregnancy Test Device (Urine/Serum) |
All lots. |
FHC-202 |
hCG One Step Pregnancy Test Strip (Urine) |
All lots. |
FHC-101 |
Issue
Product may detect low levels of HCG below the stated assay sensitivity which may result in false positive test results in samples from non-pregnant individuals. The package insert is being updated to note that low HCG levels can occur at or after onset of perimenopause. Customers should consider this when interpreting results.
Additional information
Details
Innovacon, Inc.
9942 Mesa Rim Road, San Diego, California, United States, 92121
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