Recall Z-2012-2021— Sentinel CH SpA
Class III · Ongoing
Class III FDA medical device recall by Sentinel CH SpA, initiated 2021-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001. 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..
- Recalling firm
- Sentinel CH SpA
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2021-04-30
- Firm location
- Milan, Italy
Product description
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.