Recall Z-0033-2022
Sentinel CH SpA · initiated July 29, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot 00681Y600
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0033-2022
- Initiated
- July 29, 2021
- Terminated
- July 24, 2023
- Product code
- JIS – Calibrator, Primary
- Quantity
- 32
- Distribution
- US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
- Recalling firm
- Sentinel CH SpA, Milan