Recall Z-2012-2021 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Sentinel CH SpA
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
| Date | Apr 30, 2021 |
| Status | Open, Classified |
| 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. |
| 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 refrig |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.