FDASeptember 22, 2015device
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
What to do
FDA enforcement status: Terminated
Brands named
sentinel ch spasentinelsentinel ch
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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
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- 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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