Medical Device Calibrator Kit Recall for Incorrect Labeling
FDA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled calibrator vials in Lot 00681Y600. The labeling error prevents the instrument from completing calibration successfully.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is a labeling error where the instrument's built-in detection system prevents successful calibration with incorrectly labeled vials, mitigating risk of actual misuse.
Plain-English summary
The FDA is recalling Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (catalog number 07P5605) due to incorrect labeling on calibrator vials in Lot 00681Y600. This product is used to calibrate the Alinity c CRP Vario assay on the Alinity c analyzer, which measures cardiac C-Reactive Protein.
When these incorrectly labeled vials are used, the Alinity c instrument will generate a warning that the calibrators are incorrectly loaded, and the calibration process will not be completed successfully. This prevents the instrument from accepting the calibration.
The affected calibrator kit was distributed nationwide to healthcare facilities in Louisiana, Maryland, Minnesota, North Dakota, New York, West Virginia, and Puerto Rico. Healthcare providers in these areas who have this product should verify the labeling on their calibrator vials and contact the manufacturer, Sentinel CH SpA, for replacement vials with correct labeling.
The recalled product
- Product
- Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
- Manufacturer
- Sentinel CH SpA
- Hazard
- mis-labeling
- calibration-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 00681Y600
Distribution
Distributed nationwide across the United States.
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