Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref Recalled by Sentinel CH SpA Due to Calibrator vials were incorrectly labeled. Use of incorrectly...

Date: July 29, 2021
Company: Sentinel CH SpA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sentinel CH SpA directly.

Affected Products

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.

Quantity: 32

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sentinel CH SpA

Sentinel CH SpA has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report