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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 00681Y600
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sentinel CH SpA
- Reason for Recall:
- Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot 00681Y600
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0033-2022
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