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U.S. Department of Health and Human Services

Class 3 Device Recall Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit

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 Class 3 Device Recall Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kitsee related information
Date Initiated by FirmJuly 29, 2021
Create DateOctober 06, 2021
Recall Status1 Terminated 3 on July 24, 2023
Recall NumberZ-0033-2022
Recall Event ID 88680
Product Classification Calibrator, primary - Product Code JIS
ProductAlinity 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.
Code Information Lot 00681Y600
Recalling Firm/
Manufacturer		 Sentinel CH SpA
Via Robert Koch 2
Milan Italy
For Additional Information ContactCustomer Service Department
+39 02 345 5141
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm 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.
Quantity in Commerce32
DistributionUS Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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