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ACE Control Set - IVD Control set for the quantitative… recallZ-2012-2021 · Sentinel CH SpA · initiated Apr 30, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sentinel CH SpA or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 refrigerator. Carefully remove the cap. " Gently remove the stopper to avoid loss of the lyophilized pellet and add exactly 1.0 ml of distilled or deionized water. Replace stopper and gently swirl. " Let to stand for 24 hrs at 2-8C. Swirl gently each vial immediately before use, avoiding foaming. " Take the volume necessary for the scheduled analysis. Recap and store at 2-8 C. Stability after reconstitution: 5 days when stored at 2- 8 C if contamination is avoided and vials are recapped immediately after use. Transmission of this Field Safety Notice: Please forward this notice to all the indivuals in your organization who need to be aware or to any organization/individuals where the potentially affected devices have been transferred. Reference person: If you or any of your customers have any questions regarding this information, please contact your local area Customer Service

Recall details

Recall number
Z-2012-2021
Status
Open, Classified
Initiated by the company
Apr 30, 2021
Recalling firm
Sentinel CH SpA
Quantity
1898 kits
Product code
JJX
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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