Sentinel CH SpA Via Robert Koch 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sentinel CH SpA Via Robert Koch
Lot Codes / Batch Numbers
Lot 00681Y600
Products Sold
Lot 00681Y600
Sentinel CH SpA Via Robert Koch is recalling Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in th due to Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incor. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026