| 2024-05-13 |
Class II
|
Ongoing |
Z-2174-2024 |
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, … |
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The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may su… |
| 2022-03-09 |
Class II
|
Terminated |
Z-1008-2022 |
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hoste… |
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Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software. |
| 2021-07-28 |
Class II
|
Ongoing |
Z-2354-2021 |
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 |
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Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and … |
| 2021-07-28 |
Class II
|
Ongoing |
Z-2353-2021 |
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001 |
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Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and … |
| 2021-07-28 |
Class II
|
Ongoing |
Z-2352-2021 |
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001 |
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Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and … |
| 2021-07-28 |
Class II
|
Ongoing |
Z-2351-2021 |
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, … |
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Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and … |