The FDA recently announced the recall of CoaguChek XS PT test strips, which were used with INR test meters to monitor patient response to the blood thinning drug warfarin. More than 1.1 million packages of the strips have been pulled from the market because they can give inaccurate test results, putting patient health at risk.
The FDA has categorized this recall as a “Class 1” recall, which is the most serious type of recall and indicates the use of the products could cause serious injuries or death.
Patients Advised to Stop Using Defective Test Strips
Manufacturer Roche Diagnostics sent an urgent medical device correction to healthcare professionals on September 12, 2018. In the letter, they noted that after recalibrating the test strips to the latest World Health Organization INR in January 2018, some patients began reporting abnormally high INR test results with some of the test strips.
The FDA noted in a press release that about 90 medical device reports and two serious patient injuries involving strokes were reported concerning the INR test strips. They added that incorrect INR results “are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat), who are at a high risk of stroke, or those who had a recent blood clot.”
Roche plans to re-calibrate the test strips and provide new ones to replace the defective ones and to deliver these by the end of November. Meanwhile, patients are advised to stop using the strips and check with their healthcare providers about alternative test methods available. Both patients and doctors can also contact Roche Diagnostics for more information at 1-800-428-4674. To discover if your test strips are affected by the recall, check the lot number list below.
| Product | Catalog numbers |
Affected lot numbers | |
| CoaguChek XS PT Test 2×24 Strips |
04625315160 | 28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 |
30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817 |
| CoaguChek XS PT Test 6 Strips |
04625374160 | ||
| CoaguChek XS Test 24 Tests USA |
07797826160 | ||
What is an INR Test Meter?
An INR test meter is a portable, battery-operated device used to monitor a patient’s response to warfarin, a blood-thinning drug used to help prevent blood clots. “INR” stands for “international normalized ratio,” which is a laboratory measurement of how long it takes blood to form a clot (also called “prothrombin time” or PT). The measurement helps determine if a patient needs a higher or lower dose of warfarin to keep them safe from stroke, heart attack, and other blood clot-related events.
Since response to warfarin can vary from person to person and over the course of a disease, it’s important to regularly test the blood to make sure that it’s not thinning too much—that could cause excessive bleeding—or thinning too little, which could increase the risk of a blood clot. Both doctors and patients use INR test meters to monitor warfarin’s effectiveness and adjust dosage as necessary.
To use the meter, the patient (or doctor) inserts the test strip into it, pricks a finger to get a drop of blood, then applies that blood to the meter. The meter “reads” the test strip, measures how long it takes for the blood to clot, and provides the results in the form of an INR.
The recalled units of CoaguCheck XS PT test strips were found to sometimes give inaccurate INRs.
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3 Comments
Terry Ray
My husband and I just returned from the e.r. we found out his one was 691
We were advised to go by his primary care physician, because of the blood in his stool and being light headed.
On Tuesday we were informed that the test strips were recalled, thus the blood draw, we found that his inr was 6.31.
On October 24 he had implants done at the dentist, thinking everything was okay, because his inr reading was 3.61, his normal range is 3.5 to 4.
On Fri Nov 2 he started bleeding and could not get it to stop. On Mon Nov 5 we went back to the dentist and he had to coterize his gums and stick them to get them to stop bleeding.
I have incurred medical bills and lost work time because of the inr strip being incorrect. Is there anything I can do to recoup?
Frank J Marino
I just recently started this method of tracking INR. I'm concerned that the demonstration I received at my home on October 24, 2018 that I wasn't told of the recall. I was given one of the test strips that was listed in the Class A recall (Lot #31404821). Manufacturer Roche Diagnostics sent an urgent medical device correction to healthcare professionals on September 12, 2018. This was over a month before Alere came to my home to deliver their kit including the test strips that were on the recall list. I have not thrown away the test strips yet. I have done 2 tests. The first was abnormally low, and the next one was abnormally high. Very concerned at the lack of communication on such a serious matter.
Terry Laas
I became aware of the issues of "False Readings" from Point of Care CoaguChek Test Strips and Testing Units "CoaguChek XS" before the actual "CoaguChek Test Strip Recall by Roche Diagnostics".
I contacted Roche Diagnostics Medical Affairs Department and provided the company information regarding the "Higher than Normal" readings I was seeing on my "point of care testing unit".
I was sent a "New" INR Testing Unit (CoaguChek XS) and several boxes of CoaguChek Test Strips, that appeared on the Roche Diagnostics Recall Listing.
There are numerous "point of care patients" who paid for the test strips they use, and are now being told that the test strips on the Recall Listing will not be replaced.
I have several questions regarding the "False Readings" and suggest that "point of care testing users" follow-up regarding any alteration of Warfarin or Coumadin dosing by their Healthcare Provider or Testing Provider be reviewed for potential life threatening alterations of blood thinning dosing.
1. When was Roche Diagnostics first informed by Point of Care Testing Clinics that abnormal, or false positives were being reviewed?
2. Was Roche Diagnostics contacted directly by patients using the CoaguChek XS and associated Test Strips?
3. Were patients be sent for "Blood Draw" INR Testing to compare with Potential False Test Readings from the Roche Diagnostics CoaguChek XS and associated CoaguChek XS PT Test Strips?
4. Have any patients experienced abnormal bleeding due to alterations in their Warfarin or Coumadin dose levels?
I would be interested to know if a Class Action Patient Group has been formed.
Thank You!
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