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Recall Observatory FDA recall evidence

Device 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.

Z-0033-2022

July 29, 2021

Class III

Product summary

Firm
Sentinel CH SpA
Event
Event 88680
Status
Terminated
Classification
Class III
Quantity
32
Official record key
device-enforcement:Z-0033-2022

Official wording

Reason: 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.

Code information: Lot 00681Y600

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled