FDA Medical Device Recalls (openFDA)
Sentinel CH SpA: ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
- Recall number
- Z-2012-2021
- Recalling firm
- Sentinel CH SpA
- Product
- ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
- Status
- Open, Classified
- Initiated
- 2021-04-30
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- Sentinel notified distributors by email on the 30th April 2021 and provided the letter (FSN) to be forwarded to final end-users. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. In order to use the product properly, please follow the instructions described here below. 2. Fill in all the required fields of the "Receipt of the Safety Notice" and return it to Sentinel Diagnostics; 3. Review the content of this communication with your Medical Director and retain this letter for any future reference. New procedure Take the Control REF 1667001 from the refrigerator. Carefully remove the cap. " Gently remove the stopper to avoid loss of the lyophilized pellet and add exactly 1.0 ml of distilled or deionized water. Replace stopper and gently swirl. " Let to stand for 24 hrs at 2-8C. Swirl gently each vial immediately before use, avoiding foaming. " Take the volume necessary for the scheduled analysis. Recap and store at 2-8 C. Stability after reconstitution: 5 days when stored at 2- 8 C if contamination is avoided and vials are recapped immediately after use. Transmission of this Field Safety Notice: Please forward this notice to all the indivuals in your organization who need to be aware or to any organization/individuals where the potentially affected devices have been transferred. Reference person: If you or any of your customers have any questions regarding this information, please contact your local area Customer Service
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJX
- Firm FEI
- 3000303338
- Firm city
- Milan
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28