Z-0033-2022 Class III Terminated
FDA device recall Z-0033-2022 was initiated by Sentinel CH SpA on July 29, 2021 and is designated Class III. 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 complete… The recall status is terminated (terminated July 24, 2023). Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- July 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
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.
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.
Distribution Pattern
US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Code Information
Lot 00681Y600