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Several pregnancy-test products are subject to regulator warnings or recalls after concerns that they can detect very low levels of human chorionic gonadotropin (hCG) and return a positive result when the user is not pregnant. There is no single worldwide recall covering every product. The action depends on the country, manufacturer, model and, in some cases, lot number.
The affected products include Universal Meditech tests covered by a U.S. Food and Drug Administration (FDA) safety communication, Clearview and related devices addressed by Australia’s Therapeutic Goods Administration (TGA), Innovacon devices recalled in Canada, and a specific HCG Xerion lot identified by Colombia’s INVIMA. If your test appears on a notice below, stop using it and obtain confirmation with a different authorized test or a clinician.
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Which pregnancy tests are affected?
These are separate national actions, not one worldwide notice. The dates and coverage published by each regulator are:
| Regulator and jurisdiction | Products or scope | Date and status |
|---|---|---|
| U.S. FDA | 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. They may have been distributed under other brands without identifying Universal Meditech. | Safety communication issued August 11, 2023; updated October 18, 2023. |
| Australia TGA | Clearview hCG Combo Cassette (20/10 mIU/mL), Clearview hCG Cassette (20 mIU/mL), Clearview hCG Dipstick (25 mIU/mL), and the Innovacon/InstAlert/Surestep hCG One Step Device, model FHC-102; ARTG 209317 and 212966. | Action commenced August 20, 2026; record updated August 31, 2026. Class II correction. |
| Health Canada | Innovacon hCG One Step Pregnancy Test Device, urine/serum model FHC-202, and hCG One Step Pregnancy Test Strip, urine model FHC-101. All lots are listed. | Type II recall dated September 21, 2026; notice modified October 5, 2026. |
| Colombia INVIMA | HCG Xerion pregnancy test, registration 2017RD-0004645, lot HCGSO6250. | INVIMA Alert 57-2026, published March 13, 2026. |
Product names can overlap across distributors. Match the package name, manufacturer, model, registration or ARTG number, and lot information against the notice for your country rather than relying only on the words “positive” or “one step” on the box.
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Why can a recalled test show a false positive?
Home tests use antibodies to detect hCG in urine, and some products also accept serum. The regulators’ concern is that the affected assays may react to concentrations below the sensitivity level stated for the test. That can create a positive result in a person who is not pregnant.
Health Canada specifically notes that low hCG can occur at or after the onset of perimenopause. An unexpected line can therefore have several explanations, including an assay problem, a very early or non-viable pregnancy, recent pregnancy-related hCG, medication or medical conditions. A home-test line is not a complete diagnosis, especially when it conflicts with symptoms, menstrual history or a clinician’s assessment.
What to do if you own one of these tests
- Stop using the affected product. 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.” Follow any disposal direction from your local regulator or seller if it differs.
- Check the exact identity. Record the brand, model, lot, expiration date, country of purchase and seller. This is important because some Universal Meditech products may have been sold under distributor names.
- Repeat with a different authorized test. Use a product that is not named in the applicable notice and that is legally supplied in your country. Follow its specimen, timing and read-window instructions exactly.
- Contact a health care professional when the result matters. Ask whether a laboratory blood hCG test or examination is appropriate, particularly with pain, bleeding, fainting, fertility treatment, recent pregnancy or an unexpected result.
- Report problems. In the United States, adverse events or quality concerns can be reported through FDA MedWatch. In other countries, use the reporting route given by the relevant regulator or your clinician.
How to verify a test in each country
United States
Use the FDA’s October 18, 2023 update to compare the complete product name and any Universal Meditech connection. Because the agency says distributor branding may not identify the manufacturer, packaging, purchase records and seller information can be decisive. Do not buy another box of a listed product simply because its distributor name is different.
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Australia
Check the TGA correction against the device name, model FHC-102 and ARTG numbers 209317 or 212966. The TGA advises reading the updated kit insert. A confirmed diagnosis should be made by a physician after clinical and laboratory findings have been evaluated; an alternate confirmatory test may be needed.
Canada
Health Canada’s September 21, 2026 Type II recall covers all lots of the Innovacon FHC-202 urine/serum device and FHC-101 urine strip. The notice was modified October 5, 2026, so use the current version when checking a package or a supplier’s inventory.
Colombia
Compare the package with INVIMA Alert 57-2026: HCG Xerion, registration 2017RD-0004645, lot HCGSO6250. A different lot is not automatically covered by that specific alert, but an unexpected result still warrants confirmation.
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Should you repeat the test or get a blood test?
For a low-risk, uncomplicated situation, repeating once with a different, authorized home test can identify a product-specific problem. Use a fresh sample and observe the manufacturer’s stated read time; interpreting a strip after that window can be misleading.
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How to compare a replacement test
Remove recalled products from consideration first. Then compare:
- Regulatory status: whether the product is authorized and not subject to a current notice in your country.
- Manufacturer and model: match the complete identifier, not just a familiar brand phrase.
- Lot coverage: determine whether the notice covers every lot or only a named lot.
- Specimen: confirm whether the device is for urine, serum or both.
- Analytical sensitivity: read the stated mIU/mL threshold and follow the timing instructions; a lower numerical threshold is not a substitute for clinical confirmation.
- Access to confirmation: choose a testing route that lets you contact a clinician or laboratory promptly if the result is unexpected.
What is not known
The regulators cited here have not published a reliable worldwide count of affected units or false-positive incidents. The notices establish jurisdiction-specific product concerns, not a global total. Availability and recall status can also change, so a package bought in one country should not be assumed to have the same status in another.
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