Roche Urgent Medical Device Correction

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Class 2 Device Recall Roche - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186412

Roche issued Urgent Medical Device Correction letter on March 25, 2021. Letter states reason for recall, health risk and action to take: Actions Required " Inform …

CoaguChek - INR Testing Resources - Diagnostics

https://usinfo.roche.com/HCP_UMDR.html

As a result, Roche Diagnostics issued an Urgent Medical Device Correction (UMDC) in September 2018 instructing patients and healthcare practitioners to confirm any …

URGENT MEDICAL DEVICE CORRECTION

https://diagnostics.roche.com/content/dam/diagnostics/us/en/products/a/accu-chek-inform-ii/TP-01353_UMDC_inform_II_performa.pdf

Contact Accu-Chek Customer Care at 1-800-440-3638 for product replacement if you open a sealed carton and any of the vials inside meet the criteria listed above. Please have the …

URGENT MEDICAL DEVICE CORRECTION For Clients …

https://coaguchek.ca/build/assets/files/RR201826_Version2_Client_Patient_en.c8710965.pdf

Please be advised that this Urgent Medical Device Correction RR201826 is not a product removal, as the product itself is not defective and can be used with a workaround …

Roche Diagnostics to Replace CoaguChek® XS PT Test …

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/roche-diagnostics-replace-coaguchekr-xs-pt-test-strips

Roche Diagnostics is notifying its healthcare providers, patient self-testing service providers, and distribution partner customers to arrange for replacement of all affected CoaguChek …

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device …

Urgent Medical Device Correction - Accu-Chek

https://www.accu-chek.com/sites/g/files/iut341/f/umdc_19-002.pdf

Urgent Medical Device Correction 19-002 November 06, 2019 Accu-Chek® Aviva Plus blood glucose meters with serial numbers either between 45505000001 and …

CoaguChek - INR Testing Resources - Diagnostics

https://usinfo.roche.com/PatientUMDR.html

Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek test strips to provide INR test results that correspond to the …