Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the
Summary
The FDA issued a Class III for Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Prod by Sentinel CH SpA. Reason: Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incor.
Details
Source
Device Recall
External ID
Z-0033-2022
Action Date
2021-10-13
Status
Terminated
Category
device
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.
Lot/Code Info: Lot 00681Y600
Quantity Affected: 32
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
US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-29
Company
Milan
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Sentinel CH SpA has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sentinel CH SpA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sentinel CH SpA have FDA actions?
Sentinel CH SpA has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0033-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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