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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 32
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
Related recalls
Same manufacturer · Sentinel CH SpA
See all →- HighAlinity c Iron Reagent Recalled for Falsely Elevated Test Results
FDA (Devices) · 2023-11-29
- HighIRON assay kits recalled for inaccurate diagnostic results
FDA (Devices) · 2023-11-29
- ModerateACE Control Set stability claim failure requires updated handling instructions
FDA (Devices) · 2021-07-14
- ModerateSentinel CH SpA Recalls MULTIGENT Lithium Reagent Kits
FDA (Devices) · 2019-10-02
- HighSentinel CH SpA Recalls Alinity c Lithium Reagent Kits
FDA (Devices) · 2019-10-02
Same hazard · mis labeling
See all →- HighBetterballen Foods Frozen Meat and Poultry Products Alerted for Undeclared Allergens
USDA FSIS · 2026-11-06
- ModerateEvexias Amino Ultra Recalled for Undeclared Fish Oil
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Almond Flour for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Natural Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
Similar recalls
- LowMedtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling
FDA (Devices) · 2017-07-05
- HighCystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias
FDA (Devices) · 2024-04-03
- HighSiemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Realignment Issue
FDA (Devices) · 2014-11-05
- ModerateKamiya Biomedical Recalls K-Assay Multi-Analyte Calibrator Due to Incorrect Values
FDA (Devices) · 2017-09-27
- ModerateSiemens Recalls Atellica CH High Sensitivity C-Reactive Protein Calibrator
FDA (Devices) · 2020-02-26
- ModerateSiemens ADVIA Centaur Calibrator C Recalled for Ferritin Assay Sensitivity Issues
FDA (Devices) · 2014-11-05