FDAApril 30, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

sentinel ch spasentinelsentinel ch

UPCs

08058056681775

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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