Updated on 19 October, 2021
Why was Roche CoaguChek XS PT testing ordered? What is the significance of this test strip? These are just some of the many questions that this article will try to answer. The purpose of this article is to educate the readers about the importance and uses of this testing product. Roche Company has acknowledged the importance of this product in clinical and pre-clinical development, and has taken steps to implement quality standards of these types of tests.
What caused the recall? On September 12th, 2021, Roche Coats announced the recall of approximately one percent of their CoaguChek XS PT. They issued a medical device safety update notifying healthcare providers and other patients of the potential problem this would cause. They said that this recall is being made in connection with an issue in which some test strips for the medicine Acamprosate contained an incorrect protein concentration. This problem, they said, may have serious side effects for patients who take the medicine.
How did the problem occur? It's believed that the incorrect protein level was introduced into the body during shipment. Some of the patients who received Coaguchek Xs Test Strips became sick within a few days of the company's announcement. The majority of those who became ill, or experienced other symptoms associated with these test strips, had no prior exposure to the issue. The other patients became ill after receiving the Coaguchek Xs Test Strips, and their symptoms began to worsen shortly after they stopped using the medicine.
In its statement announcing the recall of the Coaguchek Xs Test Strips, the Food and Drug Administration (FDA) noted that one of its quality inspectors noticed the error in the manufacturing process. The inspectors saw that the incorrect lot numbers were used when creating the test strips. The inspectors asked the manufacturer to supply its manufacturing process data, but so far the company has not been able to do so. The FDA is asking patients to stop using the medication while it conducts its investigation to find out how this mistake occurred.
What does this mean for patients? It means that they should stop using the Coaguchek Xs PT until the FDA can determine the source of the error. In cases where the mix of ingredients is the source of the problem, the manufacturer will be required to retest all batches. Patients should also be careful not to give their blood to anyone else while taking this drug, since the mix of ingredients could be the cause of a false result from an incorrect blood thinning test result. This could mean that a patient receives a wrong blood dose and therefore stops treatment prematurely.
This is a reminder that even small errors can have deadly consequences. For this reason, patients should always ask for a new strip and request a new batch of the Coaguchek Xs PT from the manufacturer once the results of the new strip are available. Manufacturers are usually very good at producing pharmaceutical products free of contamination. However, this does not always guarantee 100% accuracy.
For patients and health care providers who rely on these medical devices to prevent serious illness or to manage life-threatening diseases, making sure that the devices are error-free is of utmost importance. The FDA reminds patients and health care providers to follow the guidance provided by the manufacturer of each of its products. If a product has been determined to be unsafe, it should be removed from the market. Patients should not use it and must tell their doctors or trusted friends and relatives to avoid using it. Patients and healthcare providers should also report any adverse reactions they might experience to the proper authorities.
Manufacturers of Coaguchek Xs PT test strips understand the importance of ensuring that their products are error-free. They work to make sure that all of their products meet stringent manufacturing requirements. They also take great care to make sure that they don't produce any faulty products that may provide inaccurate results. If you have questions about your Coaguchek Xs PT test strips or if you think that a product your nursing has used may provide inaccurate results, you should contact the manufacturer immediately.