Roche Diagnostics to replace CoaguChek® XS PT Test Strips

INDIANAPOLIS, Oct. 31, 2018 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY): This notification supplements previous Urgent Medical Device Correction (UMDC) communications initially issued by Roche Diagnostics on September 12, 2018 and updated on October 17, 2018.

Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.

    --  Patient Self-Testers (PST) will receive replacement test strips from
        their self-testing service providers.
    --  Professional / Healthcare Providers will receive their replacement test
        strips through Roche.

The affected CoaguChek XS PT Test Strips are used with the following CoaguChek professional and patient self-testing point-of-care meters listed in the table below.

                   Healthcare Providers
                    (professional)                   Patient Self-Testers


        CoaguChek XS Professional       
     CoaguChek XS PST


       CoaguChek XS Pro                
     CoaguChek Vantus


        CoaguChek XS Plus


Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to the most recent International Normalized Ratio (INR) Standard. Since calibrating to this new standard, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected lots of CoaguChek XS PT Test Strips listed in the table below.

          Catalog Affected lot numbers


           CoaguChek XS PT Test    04625315160               28124111  30497423
          2x24 Strips                                       28124121  30497515
                                                            28631911  31404314
                                                            28631921  31404821
                                                            28631924  32264116
                                                            28632021  32264212
                                                            28632213  32264316
                                                            28632312  32264317
                                                            28632412  32264411
                                                            29415113  32264421
                                                            29415123  33045913
                                                            29494221  33046011
                                                            29494312  33046113
                                                            29494613  33046312
                                                            29494711  33046314
                                                            29778721  33046321
                                                            29779012  33046322
                                                            29779213  33449612
                                                            29779214  33449712
                                                            30497213  33449723
                                                            30497311  33449817


           CoaguChek XS PT Test    04625374160
           6 Strips


           CoaguChek XS Test 24    07797826160
           Tests USA


The lot number is printed on the test strip label, which is applied to the test strip vial. See the picture below for an example of the location of the lot number on the test strip vial.

Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

The affected test strips in the table above will be replaced with new CoaguChek XS PT Test Strips, which are not impacted by the Urgent Medical Device Correction (UMDC) and can be used without the need for confirmatory measurements with a laboratory method.

Action Required - Patient Self-Testers:
Stop using and discard any CoaguChek XS PT Test Strips listed in the table above. As of October 29, 2018, Roche started shipping newly calibrated test strips to healthcare providers and patient self-testing service providers. These test strips have been calibrated to the previous INR standard. For questions regarding when you will receive your new test strips, please contact your test strip provider. If you have any questions regarding your testing schedule, please contact your healthcare provider.

Action Required - Health Care Providers:
Stop using and discard any CoaguChek XS PT Test Strips listed in the table above. Also, please advise your self-testing patients to do the same (see above). Roche Diagnostics has started shipping unaffected test strips to healthcare providers, patient self-testing service providers and distribution partners.

Roche Diagnostics is notifying its healthcare providers, patient self-testing service providers, and distribution partner customers to arrange for replacement of all affected CoaguChek XS PT Test Strips listed in the table above. This will be executed through an updated Urgent Medical Device Correction (UMDC).

Healthcare providers and patients (self-testing customers) with questions may contact Roche Diagnostics Point of Care Technical Service by telephone at 1-800-428-4674.

Adverse reactions or quality problems experienced with the use of this product may be reported to Roche Diagnostics Point of Care Technical Service at 1-800-428-4674 and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    --  Complete and submit the report Online:
    --  Regular Mail or Fax: Download form or
        call 1-800-332-1088 to request a reporting form, then complete and
        return to the address on the pre-addressed form, or submit by fax to

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

All trademarks used or mentioned in this release are protected by law.

For further information, please contact:
Nicole Clark
Communications Business Partner
Roche Diagnostics Corporation
(317) 361-9512

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SOURCE Roche Diagnostics