Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

ACE Control Set - IVD Control set for the quantitative Recalled by Sentinel CH SpA Due to Claim for stability after reconstitution from lyophilized to...

Date: April 30, 2021
Company: Sentinel CH SpA
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sentinel CH SpA directly.

Affected Products

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

Quantity: 1898 kits

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sentinel CH SpA

Sentinel CH SpA has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report