Medical Device Recall: Z-0033-2022

FDA Recalls dataset · Firm: Sentinel CH SpA Via Robert Koch · Status: Terminated

Recall Action Class: N/A Date Initiated: 2021-07-29 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0033-2022.

Recall Res Number
Z-0033-2022
Recalling Firm / Manufacturer
Sentinel CH SpA Via Robert Koch
FEI Number
3000303338
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2021-07-29
Date Posted
N/A
Date Terminated
2023-07-24
Product Code
JIS
Event Number
88680
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.
Action Details Firm notified distributor July 29, 2021, and provided an Urgent Field Safety Notice letter to be forwarded to final end users on August 20, 2021. Customers were advised to do the following: - Immediately discontinue use of affected lot of calibrator - Destroy any remaining inventory of affected lot according to your laboratory procedures - Contact Abbott to order replacement material - Review the content of the communication with your Medical Director - Retain the letter for future reference Please forward notification to all individuals in your organization who need to be aware, or to any individuals or organizations where the recalled lot was transferred. If you have questions regarding this recall, please contact your local area Customer Service.
Distribution Pattern US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Code Information / Serial Numbers Lot 00681Y600

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.