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Recall 2018-193A: Roche Diabetes - CoaguChek - NYC - Consumer




 URGENT!!!            CONSUMER LEVEL!!!            URGENT!!!   

Description Lot # NDC
CoaguChek XS PT Test 2X24 Strips All lots in following range: 27216700
through 33449899
65702012810


Roche Diabetes is voluntarily recalling the above items/lots due to some patients experiencing abnormally high INR test results when testing with the affected CoaguChek test strips listed above. This recall is to the Consumer level.

Consumers, if you have any affected products please follow the below instructions.

• Stop using and discard any CoaguChek XS PT Test Strips listed above.
• Please contact Roche Diagnostics Point-of-Care Technical Service, 24 hours a day, seven days a week at 1-800-428-4674 to request replacement test strips or if you have questions about this recall.
• If you have any questions regarding your testing, please contact your healthcare provider.


This recall is being conducted with the knowledge of the FDA.


Contact:

Technical Support: Roche Diagnostics 800-428-4674