Health product recall

hCG Cassettes

Last updated

Summary

Product
hCG Cassettes
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 catalogue number

hCG Combo Cassette 25

All lots.

92225CA

hCG Cassette 25

All 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Abbott Rapid Diagnostics Ulc

185 Corkstown Road, Ottawa, Ontario, Canada, K2H 8V4

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82719

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe