Z-0033-2022Class III

Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) -

Name: Z-0033-2022 Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) -
Creator: Sentinel CH SpA
Published: 2021-07-29
License: https://open.fda.gov/license/

Sentinel CH SpA / initiated 2021-07-29 / Terminated / root cause: labeling and UDI

FDA source

Sentinel CH SpA began a recall of 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... on 2021-07-29. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0033-2022
Classification: Class III
Status: Terminated
Initiated: 2021-07-29
Posted: 2021-10-06
Terminated: 2023-07-24
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.
Product code: JIS Calibrator, Primary
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 32
Distribution: US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Product codes and lots: Lot 00681Y600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0033-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0033-2022	Class III	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-06

Product code JIS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)