Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MULTIGENT Creatinine (Enzymatic) Recalled by Sentinel CH SPA Due to Reagent 1 component may result in Quality Control...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sentinel CH SPA directly.
Affected Products
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
Quantity: 2356 kits Worldwide; US 206 kits
Why Was This Recalled?
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sentinel CH SPA
Sentinel CH SPA has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report