Recall Monitor
Health Products

hCG Cassettes

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: hCG Cassettes
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
hCG Combo Cassette 25All lots.92225CA
hCG Cassette 25All lots.92217CA

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.

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