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.
- CPSCSpa Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violate Virginia Graeme Baker Pool & Spa Safety Act; Sold on Amazon by Arrogantf2026-06-18
- CPSCPeg Perego Recalls Tatamia 3-in-1 Recliners, Swings and High Chairs Due to Risk of Suffocation; Violations of Multiple Federal Standards (Recall Alert)2025-06-26
- FDAsuntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245...2024-05-24
- FDAsuntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 8542450061872024-05-24
- CPSCPeg Perego Recalls Inclined Sleeper Bassinets for YPSI and Z4 Strollers Due to Risk of Suffocation and Fall Hazard; Violation of Federal Safety Standards (Recall Alert)2023-11-30
- FDAIRON assay, Reference Numbers 6K95-41 and 6K95-302023-09-29
- FDAAlinity c Iron Reagent, Reference Number 08P39202023-09-29
- CPSCSundance Spas Recalls Jacuzzi and Sundance Spas Brand Hot Tubs Due to Injury and Thermal Burn Hazards2022-12-15
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