FDA Device recall Z-2012-2021
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
- FDA Device
- Class III
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class III recall of ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001 by Sentinel Ch Spa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2012-2021 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2021-04-30 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sentinel Ch Spa |
| Distribution | US |
Product
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
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.
Identifiers
| code_info | Lot Numbers/ Exp. Date: 80516 31/07/2021; 80635 30/09/2021; 90092 31/12/2021; 90599 31/12/2021; 00118 31/12/2…Lot Numbers/ Exp. Date: 80516 31/07/2021; 80635 30/09/2021; 90092 31/12/2021; 90599 31/12/2021; 00118 31/12/2021; 00360 31/12/2021; 00610 31/12/2021; 00702 31/12/2021. UDI: 01)08058056681775( 17)210731( 10)80516(240) 1667001 {01)08058056681775( 17)210930(10)80635{240) 1667001 {01)08058056681775( 17)211231(10)90092(240) 1667001 {01)08058056681775( 17)211231(10)90599{240) 1667001 {01)08058056681775( 17)211231( 10)00118(240) 1667001 {01)08058056681775( 17)211231(10)00360(240) 1667001 {01)08058056681775( 17)211231( 10)00610(240) 1667001 {01)08058056681775( 17)211231(10)00702{240) 1667001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2012-2021%22
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