# FDA recall Z-2867-2017

> **Sentinel CH SPA** · Class II · device recall initiated 2017-05-22.

## 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

## Reason for recall

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

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-2867-2017
- **Recalling firm:** Sentinel CH SPA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-22
- **Report date:** 2017-08-09
- **Termination date:** 2018-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milan, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2867-2017

## Citation

> AI Analytics. FDA recall Z-2867-2017. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2867-2017. Source: US FDA. Licensed CC0.

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