Afinion HbA1c 1116974Recalls & reported problems
Abbott Diagnostics Technologies AS · Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 test cartridges, 1 package insert · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 24, 2025Class IIOpen, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1830-2025 · Root cause: Storage · Recall details · FDA record ↗
Other Enzymatic Method, Creatinine devices
- CLINITEK Status®+ Analyzer 10379675Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE89 reports
- ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic) 10335869Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall24 reports
- Dimension Vista® Flex® reagent cartridge ECREA 10700444Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall10 reports
- Atellica CH ECre_2 11097533Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall6 reports
- VITROS 6802584Ortho-Clinical Diagnostics, Inc. · ENZYMATIC METHOD, CREATININE52 reports
- Dimension® Flex® reagent cartridge EZCR 10471520Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall1 report
- Creatinine plus ver2 5168589190Roche Diagnostics GmbH · ENZYMATIC METHOD, CREATININE27 reports
- Creatinine plus ver2 3263991190Roche Diagnostics GmbH · ENZYMATIC METHOD, CREATININE25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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