Z-2012-2021Class III

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

Name: Z-2012-2021 ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE)...
Creator: Sentinel CH SpA
Published: 2021-04-30
License: https://open.fda.gov/license/

Sentinel CH SpA / initiated 2021-04-30 / Open, Classified / root cause: labeling and UDI

FDA source

Sentinel CH SpA began a recall of ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001 on 2021-04-30. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2012-2021
Classification: Class III
Status: Open, Classified
Initiated: 2021-04-30
Posted: 2021-07-06
Recalling firm: Sentinel CH SpA
Product: ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2012-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2012-2021	Class III	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-06

Product code JJX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)