Sentinel CH SpA: Medical Device Recall in 2021 - (Recall #: Z-0033-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product 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 Classification:

Class III

Date Initiated: July 29, 2021

Date Posted: October 13, 2021

Recall Number: Z-0033-2022

Event ID: 88680

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.

Status: Terminated

Product Quantity: 32

Code Information:

Lot 00681Y600

Distribution Pattern:

US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated