Devices

Device Recall MULTIGENT Creatinine (Enzymatic) Assay

Model / Serial
Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
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
Sentinel CH SPA
1 Event
- Recall of Device Recall MULTIGENT Creatinine (Enzymatic) Assay

Manufacturer

Sentinel CH SPA

Manufacturer Address
Sentinel CH SPA, Via Robert Koch 2, Milan Italy
Manufacturer Parent Company (2017)
Sentinel Ch. Spa
Source
USFDA

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