The Abbott Free T3 test kit recall of 2018-2019

Recently I came across the information about the Free T3 lab test assay kit recall by Abbott Laboratories announced in late 2018. The recall was initiated in October 2018 and the FDA record was published in February 2019.

The reason they list is the potential for a mistakenly lower Free T3 test result.

“Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.” In other words, the assay kits cause errors when they are processed using the machines that analyze the blood and reagent.

191,410 units total were sold, produced from their manufacturing plant in Ireland. These kits are distributed in many countries all over the world, not just in the US and Canada.

“The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.” The page was updated July 27, 2019.

HEALTH IMPLICATIONS

As discussed elsewhere in our patients’ campaign, the Free T3 test is an essential test in thyroid therapy. T3 is well known to be the most powerful thyroid hormone with direct health effects on all cells, organs and tissues in the human body.

Contemporary science has taught us a lot about the action, conversion and transport of thyroid hormone and the significance of maintaining blood levels of T3 in health. Many thyroid patients’ suffering from hypothyroid symptoms while on therapy can be due to a chronically reduced Free T3 level lower than our individual metabolic set-point, and sometimes even below the manufacturer’s or laboratory’s statistically determined reference range, as biased as that reference range boundary can be.

A low FT3 ought not to be dismissed regardless of whether a patient is critically ill, since a low FT3 is highly correlated with morbidity and mortality rates.

This is an important test whose accuracy needs to be more carefully regulated and monitored.

RECALL QUESTIONS

Of course, any recall can be a good sign of the manufacturer taking responsibility for the accuracy of its laboratory testing technologies. However, the recall communication is aimed at laboratories. The clinical and industry contexts of this test raise unanswered questions for patients concerned about the future of this test’s use in therapy.

Our fledgling campaign simply does not have the human resources to gather further research, but if you find any answers or are willing to pose any of these questions to Abbott or others, I would be happy to relay the information back to this blog.

What spurred the investigation that led to the discovery of a technical error and the decision to initiate a recall?

What didn’t meet clinical expectations with low FT3 results? Was it due to uninformed doctors being confused by the conflict between treated thyroid patients’ normal or low TSH and low FT3, or between a very high FT4 and much lower FT3? Were they finding low FT3 in patients who are not critically ill, another finding that occurs more frequently than doctors are told?

How many anomalies motivated the investigation? How many concerns or complaints does it take to initiate an investigation by a lab test manufacturer?

Do other companies recall their FT3 kits when test results are mistakenly low, or is this the only known recall of a FT3 test kit due to concerns over an inaccurate low result?

Has there ever been a recall when results were higher than expected? Or are high results more likely to be trusted by doctors and interpreted as a cause for medical action rather than assay suspicion?

Do recalls ever occur when FT3 results are within reference but inconsistent with a patient’s actual clinical symptoms and signs? Or do inquiries and recalls only occur when a result is out of range?

Is the FDA the only place one may see such recalls reported? Who regulates and requires reporting of FT3 assay kit reliability other than the manufacturers themselves, only if and when they choose to address inquiries by their customers?

THE BIGGER PICTURE

Here are the rationales behind my questions.

Too many medical and industry biases have converged to hide, recalibrate, fix, normalize, cover up, and dismiss low Free T3 test results whenever doctors think they are abnormal or unjustified. There’s a strong belief the result is merely a test artifact, not a true result.

Recalls like this tend to further reduce medical confidence in Free T3 testing, which has already suffered from many decades of medical prejudice. Over the decades, TSH monotesting policy has advanced its domination over our lifelong thyroid hormone status.

I published an article back in January 2019 on Thyroidpatients.ca questioning the validity of establishing this test’s reference range and accuracy in the lower part of the reference range. (“Abbott Laboratories’ reference range normalizes lower Free T3” )

Abbott Laboratories who not only makes these lab test assay kits and the machines that analyze them but also is the maker of Synthroid (a brand of levothyroxine, synthetic T4 thyroid hormone).

I pointed out the conflict of interest when manufacturing and marketing a Free T3 test is done by the same company that sells a drug that is well known to reduce patients’ FT3 levels per unit of TSH. Such a company would not want many patients on their medication to have low T3 results. It could lead to suspicion that the medication is ineffective for some patients, and this would obviously be bad for business. Abbott paid a price for this recall, but it was a small price given the profits it serves to protect.

LifeLabs in Ontario uses these test kits. Laboratories are in the business of ensuring that their customers have faith in their test results. However, in Canada’s health care system, there is not much market competition between laboratories when there is only one or two companies providing the service in a given region. So laboratories just have to look like they care about their test validity and reliability to please their biggest customers.

It is highly likely that this is the 2018 recall that spurred LifeLabs Ontario to change its reference ranges and as a result, they shifted their reference ranges lower. Perhaps they participated in the recall and received new assay kits in exchange for them. Whatever the case, LifeLabs felt the need to do a poorly designed recalibration of their reference on less than 100 random anonymous blood samples, with no way of ensuring that the samples were from healthy people’s blood (see LifeLabs Twitter replies to patients in 2019). It was uncanny that the reference range they obtained was almost exactly the same as Abbott’s manufacturer-recommended reference range, when laboratory ranges for FT3 vary to a wide degree from lab to lab, region to region.

Endocrinologists also have a stake in such a recall. In addition to discouraging all FT3 testing in all but suspected hyperthyroidism, they don’t want too many treated thyroid patients to have anomalous low Free T3 results.  If too many doctors see the frequency of lower FT3 in treated thyroid patients, it would be bad for medical faith in TSH monotesting policies and thyroid therapy guidelines that endocrinology associations like the American Thyroid Association have upheld for decades.  If low T3 test results are indeed trustworthy AND more common than believed, it might just show that there is a reason for serious concern over the effectiveness of standard thyroid therapy.

This concern to fix or explain away Low T3 anomalies and to reduce faith in T3 testing is a clear sign of industry and medical bias. In this environment, doubts and errors on the low end of the FT3 scale must be exaggerated so that low FT3 can continue to be ignored by policy and dogma. This policy is in direct conflict with research findings that clearly associate low blood levels of FT3 with various diseases and serious health concerns (see various research reviews on this blog).

Endocrinology continues to refuse to acknowledge thyroid therapy’s major side effect, a net global T3 hormone loss. They continue to permit the widespread medical myth that TSH is an omniscient judge of T3 sufficiency in all peripheral tissues during therapy and that its judgment trumps Free T3 lab results. Major endocrinology associations unwisely support international “Choosing Wisely” health care cost-savings campaigns labeling Free T3 as an “unnecessary” lab test in hypothyroid therapy.

A limited market for the Free T3 test is the result.

In this system, not much money can be gained by enhancing the Free T3 test to make it more sensitive and accurate at lower concentrations like the TSH test is. Bandaid solutions like recalls are all that the system is willing to do, and this just erodes trust.

It contributes to medical apathy regarding the refinement, standardization, and lack of third-party regulation of this test.

These biased testing beliefs and policies have contributed to mass ignorance of many patients’ suffering with hypothyroid symptoms and health problems, and a lack of research on the correlation between treated patients’ FT3 levels and long term health and well being.

Most studies of low FT3 and diseases entirely exclude treated thyroid patients from study, so patients who are at risk of low FT3 due to medication underdose, poor response to therapy, or medication side effect are never being studied.

Patients and a minority of good thyroid doctors and researchers, on the other hand, are the only ones who seem to be emphasizing the importance of measuring and avoiding a low Free T3. They are the ones who seem to be painfully aware of the effects of a low FT3 and equally aware of the healing and wellness that can be achieved when FT3 is optimized to the individual’s metabolic needs.

Come on, let’s enhance Free T3 testing so we can stop treating its results with suspicion whenever FT3 is dangerously low, whenever it contradicts the false god of TSH, and casts doubt on the false dogma that T4 monotherapy works for everyone with a thyroid disability!

FDA RECALL NOTICE: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=168630