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

Is my product affected?

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

• UPC 08058056681775

Check against the official notice below — it lists the full affected range.

What happened

Sentinel CH SpA is recalling its ACE Control Set (Reference 1667001), an in vitro diagnostic control product used for measuring Angiotensin Converting Enzyme levels. The recall affects 1,898 kits distributed worldwide, including throughout the United States and 26 other countries. The recall was initiated because the product's stability after being reconstituted from its lyophilized (freeze-dried) form to liquid does not meet the manufacturer's claims, which could affect the accuracy of test results.

The affected kits have eight specific lot numbers with expiration dates ranging from July 31, 2021 to December 31, 2021. Sentinel CH SpA has provided updated instructions for handling the product to end users. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. 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. Quantity: 1898 kits Lot/code info: Lot Numbers/ Exp. Date: 80516 31/07/2021; 80635 30/09/2021; 90092 31/12/2021; 90599 31/12/2021; 00118 31/12/2021; 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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