PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 9, 2017 Initiated: May 22, 2017 #Z-2867-2017

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

Reason for Recall

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

Details

Recalling Firm
Sentinel CH SPA
Units Affected
2356 kits Worldwide; US 206 kits
Distribution
Nationwide Distribution
Location
Milan, N/A

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Sentinel CH SPA. Units affected: 2356 kits Worldwide; US 206 kits.
Why was this product recalled? ▼
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2017. Severity: Moderate. Recall number: Z-2867-2017.

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