FDAJuly 29, 2021device
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
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.
- 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, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 8542450061872024-05-24
- 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
- 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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