iTechGuides is reader-supported. When you buy through links on our site, we may earn an affiliate commission. As an Amazon Associate I earn from qualifying purchases. Learn more
Several pregnancy-test products are subject to regulator warnings or recalls after reports and investigations found a risk of false-positive results. There is no single worldwide recall covering every test: the affected products differ by country, model, lot and regulator. The current actions involve the U.S. Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada and Colombia’s INVIMA.
Which pregnancy tests are affected?
Use the regulator and product details for the country where you bought the test. A similar brand name does not prove that a product is included, while some products may have been sold under distributor labels that do not clearly identify the manufacturer.
| Jurisdiction and action | Affected products | Specimen, sensitivity or lot scope |
|---|---|---|
| United States — FDA safety communication, issued August 11, 2023 and updated October 18, 2023 | Universal Meditech products including One Step Pregnancy Test; To Life hCG Pregnancy Urine Test; Am I Pregnant Pregnancy Midstream Test; DeTec hCG Pregnancy Urine Test; PrestiBio Pregnancy Strips and Rapid Detection Pregnancy Test Midstream; and DiagnosUS and LEM Fertility hCG formats. | The FDA says these products may have been sold under distributor brands without identifying Universal Meditech. A sensitivity value or complete worldwide lot count was not stated in the safety communication. |
| Australia — TGA Class II correction, action commenced August 20, 2026; record updated August 31, 2026 | Clearview hCG Combo Cassette; Clearview hCG Cassette; Clearview hCG Dipstick; and the Innovacon/InstAlert/Surestep hCG One Step Device, model FHC-102. | Clearview sensitivities are 20/10 mIU/mL for the Combo Cassette, 20 mIU/mL for the Cassette and 25 mIU/mL for the Dipstick. The devices are listed under ARTG 209317 and 212966. |
| Canada — Health Canada Type II recall dated September 21, 2026; notice modified October 5, 2026 | Innovacon hCG One Step Pregnancy Test Device, model FHC-202, and hCG One Step Pregnancy Test Strip, model FHC-101. | FHC-202 is intended for urine or serum; FHC-101 is for urine. Health Canada lists all lots. |
| Colombia — INVIMA Alert 57-2026, published March 13, 2026 | HCG Xerion pregnancy test. | Registration 2017RD-0004645; affected lot HCGSO6250. |
If your box, insert or receipt does not show the model or lot clearly, do not assume it is safe based only on the retail brand. Check the current notice from the regulator in your country or ask a pharmacist or clinician to identify it.
What’s actually slowing this PC down?
Pick the symptom - the matching free tool is one click away.
Why these tests can produce a false positive
Detection of very low hCG
The TGA and Health Canada describe the same technical concern: an affected assay may detect very low amounts of human chorionic gonadotropin (hCG) below the test’s established sensitivity level. That can produce a positive result in someone who is not pregnant. The result may appear as a line or other positive indicator even though the person does not have a confirmed pregnancy.
#1 Best Overall
- RAPID DETECTION PREGNANCY TEST: Includes two (w) Clearblue Rapid Detection Home Pregnancy Tests that can give you a result as fast as 1 minute[1]
- EASY TO USE: The extra-wide tip changes color to show you’ve hit the target. The comfortable-to-hold, long, curved handle for easy sampling also helps maintain hygiene
- EASY-TO-READ RESULTS: Clear plus (+) or minus (-) result
- OVER 99% ACCURATE: Over 99% accurate at detecting pregnancy from the day you expect your period[2]
- FLOODGUARD(TM) TECHNOLOGY: Helps cut down on #1 reported usage error by +70%[3]
Perimenopause can complicate interpretation
Health Canada notes that low hCG can occur at or after the onset of perimenopause. A faint or unexpected positive in that setting needs clinical context; it should not be treated as proof of pregnancy without confirmation. Perimenopause is one possible explanation for low hCG, not a diagnosis of the test result.
What to do if you own or used an affected test
- Stop using it. The FDA’s instruction is: “Do not use or purchase the tests listed above.”
- Remove it from your supplies. The FDA says to “Immediately stop using and destroy these recalled tests by placing them in the trash.” Keep the packaging until you have recorded the product name, model and lot for a clinician or regulator.
- Repeat with a different pregnancy test. If you still want a home-test result, use a product that is not included in the applicable recall or correction. The FDA specifically advises testing again with a different test.
- Contact a health care provider when the result matters. Discuss an unexpected positive, a result that conflicts with symptoms or menstrual history, or any concern about accuracy. A clinician can decide whether an alternate laboratory or other confirmatory test is appropriate.
- Report problems. In the United States, adverse events or quality concerns can be reported through FDA MedWatch. In other countries, use the reporting channel named in the local regulator’s notice.
How an unexpected positive should be confirmed
A home test is a screening result, not a complete diagnosis. The TGA states that “a confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.” When a recalled product, perimenopause, symptoms or another medical circumstance makes the result uncertain, a clinician may use an alternate test and laboratory findings rather than relying on the original device.
Rank #2
- Portable and discreet, test anywhere, anytime
Do not delay urgent medical care for severe pain, heavy bleeding, fainting or other emergency symptoms while trying to resolve a home-test discrepancy. Those symptoms require prompt clinical assessment regardless of the device used.
Do these 3 things before closing this tab:
1Fix the driver behind crashes, sound loss and screen glitches2Clear out junk files and repair common Windows errors3Scan for outdated or missing drivers - takes under a minuteIf your test is not on the listed notices
- Verify the manufacturer, exact model, specimen type and lot number rather than matching only a product family name.
- Check the regulator for the country where the test was supplied. A product can be subject to action in one jurisdiction without appearing on another country’s notice.
- Follow the current package insert and expiry information. If a positive result is unexpected, repeat with a different authorized test and seek clinical confirmation.
- Do not infer safety from online listings or a seller’s description; authorization and recall status can change by geography and date.
What is not known
The reviewed regulator notices do not provide a reliable worldwide total for affected units or false-positive incidents. The actions should therefore not be interpreted as a count of every test sold or every person who received an incorrect result. They identify specific products, models or lots within each regulator’s jurisdiction.
Rank #3
- Specially designed for women trying to conceive: These easy@Home ovulation tests help women predict their fertile days, even if their cycle lengths vary
- The ovulation test strips help to track your ovulation progression, and minimize the chances of missing your LH surge. Levels of hCG as low as 25 mIU/mL can be detected in 5 minutes
- Easy to Use: Simply dip the test in your urine until the dye rises into the result window (approximately 5 - 10 seconds)
- Easy to Read: Ovulation tests -- a test line as dark or darker than the control line indicates a positive result. Pregnancy tests -- two lines means pregnant and one line means not pregnant
- Trust support with easy@Home: We are committed to providing high-quality products and exceptional customer service. Our products have helped millions of families achieve their dreams of having a baby quickly and easily
Key takeaway for readers
First identify the country, manufacturer, model and lot. If the product matches a listed action, stop using it, discard it as directed and repeat testing with a different product. Treat an unexpected positive as unconfirmed until a physician has evaluated the clinical and laboratory evidence.
Quick Recap
Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.
