FDA Medical Device Recalls (openFDA)
Sentinel CH SpA: 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 number
- Z-0033-2022
- Recalling firm
- Sentinel CH SpA
- 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.
- Status
- Terminated
- Initiated
- 2021-07-29
- Posted
- not on file
- Terminated
- 2023-07-24
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 32
- Distribution
- US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
- Lot, serial or model codes
- Lot 00681Y600
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIS
- Firm FEI
- 3000303338
- Firm city
- Milan
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28