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Recall Observatory FDA recall evidence

Device product

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

Z-2012-2021

April 30, 2021

Class III

Product summary

Firm
Sentinel CH SpA
Event
Event 88040
Status
Ongoing
Classification
Class III
Quantity
1898 kits
Official record key
device-enforcement:Z-2012-2021

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.