Lower riskMedical device recall · FDA · Published July 29, 2021
Sentinel CH Alinity c CRP Vario Calibrator Kit: Incorrect Labeling Causes Calibration
Sentinel CH recalls Alinity c CRP Vario Calibrator Kit (ref 07P5605) due to incorrect vial labeling, which may prevent successful calibration of cardiac tests on Alinity c analyzers.
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.
Take action
Contact the company
📍Recalling firmSentinel CH SpAVia Robert Koch 2 · Milan, Italy
“Sentinel CH Alinity c CRP Vario Calibrator Kit: Incorrect Labeling Causes Calibration.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62121-sentinel-ch-alinity-c-crp-vario-calibrator-kit-incorrect-labeling. Based on FDA recall #Z-0033-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0033-2022%22&limit=1).
Sentinel CH SpA recalled the Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled vials that prevent successful calibration, according to the FDA on July 29, 2021. The agency announced the voluntary Class III recall via record Z-0033-2022.
How to tell if you have it
Brand: Sentinel CH
Product: Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605)
Lot: 00681Y600
The hazard
The FDA stated that the calibrator vials were incorrectly labeled. Use of these vials causes the instrument to generate a warning that calibrators are incorrectly loaded and prevents calibration from completing successfully.
Context
GovInfoNow's records show Sentinel CH SpA has issued three other recalls since June 28, 2019. Other recent recalls of similar products include Medline PPE Kit DYK1011945P (Jan. 7, 2026) and Medline Convenience Kits Recall (Jan. 7, 2026).
How to tell if you have this one
Check for the product name 'Alinity c CRP Vario Calibrator Kit' with reference number 07P5605. The kit was sold with lot number 00681Y600.
Brand
Sentinel CH
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Vial Labels
Verify that the vials are correctly labeled for the Alinity c CRP Vario Calibrator Kit (ref 07P5605).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Louisiana, Maryland, Minnesota, New York, North Dakota, Puerto Rico, West Virginia.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0033-2022 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0033-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.