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...
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.
About Sentinel CH SpA
Sentinel CH SpA has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report