Public recall detail

hCG Cassettes

2026-10-02

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Health products Health product recall
Quick summary

Quick summary: hCG Cassettes. Reason: Health product recall. Category: Health products. Date: 2026-10-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: hCG Cassettes. Reason: Health product recall. Category: Health products. Date: 2026-10-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbbott Rapid Diagnostics Ulc
ProducthCG Cassettes
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82719

Affected products

ProducthCG Combo Cassette 25
LotAll lots.
Model92225CA
Serial numberAll lots.
DescriptionhCG Combo Cassette 25
ProducthCG Cassette 25
LotAll lots.
Model92217CA
Serial numberAll lots.
DescriptionhCG Cassette 25

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesAbbott Rapid Diagnostics Ulc 185 Corkstown Road, Ottawa, Ontario, Canada, K2H 8V4
Recall date2026-09-21
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82719
Background{}
CompaniesAbbott Rapid Diagnostics Ulc 185 Corkstown Road, Ottawa, Ontario, Canada, K2H 8V4
AudiencesHealthcare
Source updated2026-10-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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