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Roche Diabetes Care, Inc. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, Class IIMay 13, 2024The reason for recall is the meters may show an incorrect me |
| RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosteClass IIMar 9, 2022Potential for patient data mismatch when using browser "back |
| Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001Class IIJul 28, 2021Test strip vials may open while inside sealed cartons during |
| Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001Class IIJul 28, 2021Test strip vials may open while inside sealed cartons during |
| Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, Class IIJul 28, 2021Test strip vials may open while inside sealed cartons during |
| Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001Class IIJul 28, 2021Test strip vials may open while inside sealed cartons during |