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Alert for Patients on Warfarin: Roche Recalls Potentially Defective INR Test Strips
Chaffin Luhana LLP
(888) 480-1123

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

CoaguCheck XS PT Test Strip RecallManufacturer 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.

3 Comments

  1. Gravatar for Terry Ray
    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?

  2. Gravatar for Frank J Marino
    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.

  3. Gravatar for Terry Laas
    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!

Comments are closed.