Current Issues & Alerts
Recalls, problems, and other notes
Last Updated March 2007

1. Possible false positives on blue +/- tests ongoing issue; current as of March 2007

I have received some initial reports that various brands of the blue +/- tests (see The +/- Tests for brand examples) may be giving false positive results. The vertical line that appears to form the + sign shows up during the 10-minute valid result time frame, but is very narrow and slightly off-center (to the left.) Several women who have experienced this have gone on to have negative blood results and/or bleeding.

While it remains difficult to distinguish a false positive test from a very early miscarriage, it is suspected when all other brands/tests are clearly negative, a blood test is negative, and menstrual bleeding occurs around the expected date. Furthermore, a genuine positive will likely have a thicker vertical line in the + window, though the left edge is often darker.

If you think you may have experienced a false positive (or you experienced a very skinny + sign and were indeed pregnant after all) please let me know!

If you get a result like this, I suggest testing again with a different brand of comparable sensitivity. If you believe your test was falsely positive, you can contact the manufacturer to complain and request a refund. Manufacturer's contact information is available on the test box, on the instructions that came with the box, or on this website (visit the HPT Overview and click on a brand.)

2. Recall on Confirm Clearly digital test due to false positives ongoing issue; current as of December 2006

Confirm Clearly is voluntarily withdrawing their tests from the market due to "an unexpected amount of consumer complaints" (per the rep I spoke to today.) If you have purchased this test, save the box until you have called:

and given the lot number, purchase price, and various other sundry facts to the representative. Alternately, you can use:

Refunds will be issued to women who purchased these tests. (The rep said you may throw the tests away, but I say please consider donating them to me! I've wanted to play with them and never found them locally!)

Meg Clarke
P.O. Box 1425
Laurel, MD 20725

Background: I first mentioned issues with this test in September, after approximately 20 women e-mailed me with complaints. A few husbands, one kitchen sink, and one neutered dog even tested positive using this brand. I have been unable to find the test locally, though I've looked everywhere! (Even 4 days postpartum . . .)

To date, I've had about 50 complaints from women about false positives on this test. .

And if you see this test in the stores-- buy it and donate it to me! I want to see one of these heinous liars in action . . .

3. False positives on Clearblue, e.p.t., and generic digital tests: some confirmed incidents ongoing issue; current as of October 2006

In October 2005, after receiving e-mail from several women complaining of false positives on digital tests (e.p.t. Certainty, Clearblue Easy Digital, and various generic digital brands inclusive) I reported the claim here and asked for more information and anecdotes.

In the months that followed, I did receive more e-mail on this subject-- about 20 more women reported "Pregnant" readings followed by subsequent negative tests and bleeding.

It is difficult to confirm a false positive vs. early miscarriage (many women test positive and proceed to have a period-like bleed; this is also known as a "chemical pregnancy.) Even blood tests can't always confirm this, since hCG dissipates from the blood before it leaves the urine, meaning that a blood beta can be negative while a urine pregnancy test is still positive (for a short time.)

However, these reports are credible for a few reasons; for instance, many of these women continued to test negative on all other brands of test; again, it is less likely that a digital test would confirm pregnancy "in isolation" with no other tests ever becoming positive. Some women managed to confirm, without a doubt, that they were never pregnant-- some of them tested (obsessively? ;) prior to ovulation, when pregnancy was not yet even possible.

The difficulty in gauging the size of the problem with the digital tests is that I have no data on how many women have used the test with accurate results as opposed to those who have received false positives; I have only anecdotal reports. I'm sure tens of thousands of women have used the test with accurate results, myself included. It is still much more likely that the word "Pregnant" on your digital test indicates pregnancy than a false positive.

But, it does appear that, on occasion, a "Pregnant" reading may be an error. If you have doubts about your results, consider confirming results with a different brand of test.

If you have experienced what you believe to be a false positive on a digital test, please tell me about it and be sure to telephone the manufacturer's 800# (see the box, instruction leaflet, or find it through the HPT Overview) to request a refund or replacement test.

4. Answer Early & First Response Early Result: issues with disappearing "positive" lines ongoing issue; latest report in October 2006

Please note: both tests have recently been redesigned. The reports all pertain to the old test design.

Many women have contacted me regarding these brands of tests (interestingly, both tests are manufactured by the same company.) These women have noted that shortly after applying urine to the tests, a pink result line appears in addition to a pink control line (a "positive" result.) However, anywhere from a few minutes to a few hours later, the pink result line disappears completely, appearing to be a negative test.

Both the First Response Early Result and Answer Quick & Simple Early Result leaflet state, "A positive result will last for at least 48 hours."

Some of the women informed me that they called the manufacturers' 800#s and were told that sometimes, in very early pregnancy, there is not "enough hCG to make the line stick." Other women who also called the 800#s were told by other representatives that a disappearing line should be regarded as a negative test altogether. Others were told the test was positive, even if the line disappears. So, there seems to be quite a bit of confusion involved among the company representatives.

For awhile, I was compiling the results of women who reported this to me. Of the first 67 individual women who experienced "disappearing positives," 2 experienced results that indicated probable miscarriage (additional positive tests, but later experienced bleeding.) 7 women confirmed pregnancy, 31 confirmed they were not pregnant, and 26 women failed to update me. Now I am receiving so many reports of this (with the vast majority of women not pregnant) I am no longer compiling exact numbers.

In light of this information, and the statement that "A positive result will last for at least 48 hours," I suggest that all "disappearing positives" should be treated as negative tests. It is common for women to see false negative pregnancy tests (usually testing before there is sufficient hormone in the urine to be detected) so even those women who did turn out to be pregnant experienced results that should be considered negative.

Additionally, I was collecting and presenting the lot numbers of these tests, but the issue does not seem to be confined to a specific batch. Many lot numbers were affected, but not every test with a particular lot number had this issue. Therefore, I have removed those lot numbers from this site. It was not providing any helpful information.

I would recommend, at this time, that Answer Early and First Response Early Result brand pregnancy tests be avoided. If the "disappearing line" phenomenon occurred prior to the 10-minute time limit, it would be easy to use the test successfully; it would require merely reading it at the 10-minute mark and disposing of it. However, several of the women who reported this issue to me noted that their line disappeared after this all-important time limit, anywhere from 30 minutes to 4 full hours later. In my opinion, this is unacceptable. A positive result "should" last 48 hours, but it should not require that a woman wait 48 hours to ensure the line is still present and thus truly positive.

Additionally, I am disturbed by the fact that the customer service representatives present different information to different callers. A pregnancy test result is one of the most important and life-changing pieces of information a woman will ever get, and it seems women using Answer Early and First Response Early Result at this time are receiving ambiguous information from the tests and the company representatives who are supposed to help clarify.

If and when this issue is resolved, I will be happy to reevaluate the accuracy and reliability of the AE and FRER tests. As of last status update, I am still receiving e-mail complaints about these tests.

5. Clearblue Easy Earliest Results, Fact Plus Pro, e.p.t. +/- results window: faint but visible false positives common, "positives" commonly develop after 10-minute limit, and negative results are faint ongoing issue; current as of September 2006

Please see The +/- Tests section for a complete description, analysis, and photographs.

New: Equate tests are now +/-. However, the dye is pink, not blue, and initial reports are mostly positive (ha ha.) The horizontal "n"-line disappears after a day or so, but the positive vertical line stays.

6. B-Sure recall March 25, 2005

As of March 25, the distributor of these tests, Harmony Brands, is recalling this test because "its safety and efficacy can no longer be assured." According to the FDA release, "Consumers who have unused & unexpired B-Sure brand One-Step Home Pregnancy Test in their possession should not use the product and should return the product to the point of purchase for a refund. Additionally, women who have used the test may wish to contact their health care provider to verify the test results."