ACE Control Set — Class III medical device recall Z-2012-2021
Ongoing recall by Sentinel CH SpA, reported 2021-07-14, distributed nationwide. Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New I
| Recall number | Z-2012-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentinel CH SpA, Milan, Italy |
| Recall initiated | 2021-04-30 |
| Classified | 2021-07-06 |
| Reported by FDA | 2021-07-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, CA, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HR, IE, IL, IT, JO, NL, NZ, PL, PT, RS, SE, TR, ZA |
| Quantity | 1,898 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 08058056681775 |
| Lot numbers | 00118, 00360, 00610, 00702, 30/09/2021, 31/07/2021, 31/12/2021, 80516, 80635, 90092, 90599 |
| Model numbers | 1667001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2012-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.