FDA has warned patients and doctors that inaccurate results provided by Roche's CoaguChek test strips could cause serious injuries or death in patients taking the blood thinner warfarin.
Roche started recalling the strips in September after learning that the devices were providing abnormally high international normalized ratio (INR) values, potentially leading patients to erroneously change their warfarin doses.
FDA categorized Roche's action as a Class I recall after receiving reports of two serious patient injuries involving strokes.
The doctors of the millions of Americans who take warfarin to thin their blood need to know how quickly their patient's blood clots. This information informs decisions about the extent to which the drug is thinning the blood and, by extension, whether the dose needs modifying. Failure to maintain an effective dose can lead to dangerous blood clots in patients who have mechanical heart valves, suffer from atrial fibrillation or are otherwise at risk of cardiovascular events.
Roche's CoaguChek device and associated test strips free patients from the need to have blood taken from a vein for analysis by a laboratory. Instead, they are tested at home or the doctor's office using a fingerstick blood draw similar to those used by diabetics to test blood glucose levels.
The devices can deliver INR results that are accurate enough to be useful but began generating false findings after Roche calibrated the strips to the latest World Health Organization international reference preparation at the start of the year. FDA has received 90 medical device reports and learned of two serious patient injuries involving strokes since the system was re-calibrated.
Roche warned healthcare professionals about the fault in September and began pulling the affected strips from the market. Last month, Roche expanded the recall. In total, Roche is recalling more than 1.1 million packs of CoaguChek XS PT distributed across the U.S. over the first 10 months of 2018. Roche has asked patients and doctors to stop using the recalled strips.
Shipments of test strips calibrated to the old WHO standard began leaving Roche facilities at the start of the week. FDA has reviewed validation data on the re-calibrated strips and expects them to be in the hands of patients and healthcare professionals by the end of the month.
Problems with other devices have affected the availability of alternative point-of-care devices. After a decade of quality problems, Alere initiated a Class I recall of its INR test in 2016. FDA said Alere was "unable to develop an adequate modification that ensured the safety and effectiveness of the INRatio System." CoaguSense brought a rival device to market in 2010 but sold up to Korea's i-SENS in 2016.