Sentinel CH SPA recalls MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination

Recalled August 9, 2017 · FDA recall Z-2867-2017 · Sentinel CH SPA

Hazard

Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration. · FDA Class II

Units

2356 kits Worldwide; US 206 kits

Sold at

Nationwide Distribution

Description

Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.

Product

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

Manufacturer(s)

Sentinel CH SPA

Made in

Italy

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →