# FDA recall Z-2012-2021

> **Sentinel CH SpA** · Class III · device recall initiated 2021-04-30.

## Product

ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE)    REF 1667001

## Reason for recall

Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements.    New IFU instructions for handling the product provided to end users.

## Distribution

Worldwide distribution - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CANADA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, JORDAN, NEW ZEALAND, POLAND, PORTUGAL, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, THE NETHERLANDS, TURKEY, U.A.E., UK.

## Key facts

- **Recall number:** Z-2012-2021
- **Recalling firm:** Sentinel CH SpA
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-30
- **Report date:** 2021-07-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milan, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2012-2021

## Citation

> AI Analytics. FDA recall Z-2012-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2012-2021. Source: US FDA. Licensed CC0.

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