Test strips used for home monitoring of patients taking the blood
thinner warfarin may have caused serious injuries or death due to inaccurate readings,
leaving legal action as the only remedy for innocent patients and their
On Sept. 13, 2018, the U.S. Food and Drug Administration
(FDA) initiated a Class I recall — the most serious type of recall — of more
than 1.1 million packages of CoaguChek XS PT Test Strips
manufactured by Roche Diagnostics. Although this recall was initiated in
September by the FDA, the recall was not announced until Nov. 1, 2018; this
recall affected CoaguChek XS test strips that were distributed nationwide from
Jan. 12, 2018 to Oct. 29, 2018. The test strips were used with CoaguChek test
meter devices, which use blood drawn from a finger prick to determine a
patient’s International Normalized Ratio (INR) score. INR is the measurement of
how much time it takes for the patient’s blood to clot.
The meters were used directly by patients as well as by some
The FDA’s warning was based on medical device reports
submitted by Roche Diagnostics to the agency indicating that the test strips
may have provided results that were higher than the actual INR. According to
Roche, the problems with the test strips arose when it recalibrated them to a
new international standard. The company has since replaced the defective test
strips with new test strips calibrated to the previous INR standard. Roche did
not begin shipping the recalibrated test strips until Oct. 29, 2018.
What Injuries Are
Associated with Roche CoaguChek XS PT Test Strips?
Inaccurate test strip readings may have resulted in some
patients being prescribed an insufficient warfarin dose or having been instructed
to interrupt warfarin use, putting them at increased risk for dangerous blood
Blood clots can cause:
What Is Warfarin
Warfarin (also known by the brand names Coumadin and
Jantoven) is an anticoagulant (blood thinner) that is used to prevent or treat
blood clots. It may be prescribed for patients with certain types of irregular
heartbeats, blood clots in the legs or lungs, or certain medical device
implants such as artificial heart valves.
Patients taking warfarin require meticulous monitoring with regular
blood tests, often weekly or even more frequently, to adjust their dosage to
keep their blood-clotting time within a safe target range.
How Do I Know If My
CoaguChek XS PT Test Strips Were Recalled?
The recall included the following test strips:
To determine whether your CoaguChek XS PT Test Strips were
included in the recall, check the lot number printed on the test strip label, which
is applied to the test strip box and the test strip vial.
The following CoaguChek XS PT Test Strips lot numbers were recalled:
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
What Should I Do If I
Have CoaguChek XS PT Test Strips That Were Recalled?
Patients should not to use the recalled test strips. They can
use the recalibrated test strips, or in the alternative, INR testing can be
performed by an accredited laboratory on blood drawn from a vein.
Patients should consult with their healthcare provider
before making any changes to their warfarin dose.
What Should I Do If I
Believe I (Or a Loved One) Was Injured by CoaguChek XS PT Test Strips?
Tanner, an attorney at Feldman Shepherd who has litigated numerous cases
involving defective medical devices, said that when poorly designed or
inadequately tested medical devices cause injury, manufacturers must be held
“Regrettably, unsafe drugs and devices are still marketed to
the public even after evidence of unacknowledged hazards becomes known to the
manufacturer. Only the civil justice system can hold those manufacturers
accountable and provide justice to those that are harmed unnecessarily by these
products,” Tanner said.
Tanner recommends contacting an unsafe
medical device attorney as soon as possible if you believe that you or a
loved one was injured by CoaguChek XS PT Test Strips, as every state has its
own strict deadlines as to when a lawsuit must be filed. If you still have the
affected test strips, you should not discard them, as they are important
evidence in litigation, Tanner said.
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