Class III — Sentinel CH SpA
| Recalling firm | SENTINEL CH. SpA |
|---|---|
| Registered facility | SENTINEL CH. SPA (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | 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. |
| Product | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001 |
| Quantity | 1898 kits |
| 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. |
| Initiated | 2021-04-30 |
| Classified | 2021-07-06 |
| Recall number | Z-2012-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Sentinel CH SpA (Z-2012-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88040/
Alerts for SENTINEL CH. SpA
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.