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Sentinel CH SpA recalls ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 16670
Recalled July 14, 2021 · FDA recall Z-2012-2021 · Sentinel CH SpA
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. · FDA Class III
Units
1898 kits
Sold at
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.
Description
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.
Product
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Manufacturer(s)
Sentinel CH SpA
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →