# FDA recall Z-2586-2017

> **Medtest Holdings, Inc.** · Class II · device recall initiated 2012-03-13.

## Product

Pointe Scientific Hitachi Total Bilirubin Rl Reagent    Product Usage:  Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

## Reason for recall

Decrease reactivity of R 1 component.

## Distribution

Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE

## Key facts

- **Recall number:** Z-2586-2017
- **Recalling firm:** Medtest Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2012-03-13
- **Report date:** 2017-06-21
- **Termination date:** 2017-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canton, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2586-2017

## Citation

> AI Analytics. FDA recall Z-2586-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2586-2017. Source: US FDA. Licensed CC0.

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