Sentinel CH SpA: Medical Device Recall in 2021 - (Recall #: Z-2012-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

Product Classification:

Class III

Date Initiated: April 30, 2021

Date Posted: July 14, 2021

Recall Number: Z-2012-2021

Event ID: 88040

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.

Status: Ongoing

Product Quantity: 1898 kits

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated