Public recall detail

hCG One Step Pregnancy Tests

2026-10-02

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Health products Health product recall
Quick summary

Quick summary: hCG One Step Pregnancy Tests. 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 One Step Pregnancy Tests. 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.

BrandInnovacon, Inc.
ProducthCG One Step Pregnancy Tests
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82718

Affected products

ProducthCG One Step Pregnancy Test Device (Urine/Serum)
LotAll lots.
ModelFHC-202
Serial numberAll lots.
DescriptionhCG One Step Pregnancy Test Device (Urine/Serum)
ProducthCG One Step Pregnancy Test Strip (Urine)
LotAll lots.
ModelFHC-101
Serial numberAll lots.
DescriptionhCG One Step Pregnancy Test Strip (Urine)

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
CompaniesInnovacon, Inc. 9942 Mesa Rim Road, San Diego, California, United States, 92121
Recall date2026-10-21
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82718
Background{}
CompaniesInnovacon, Inc. 9942 Mesa Rim Road, San Diego, California, United States, 92121
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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