# FDA recall Z-0489-2019

> **Merck Millipore Ltd.** · Class II · device recall initiated 2018-05-14.

## Product

Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15)    Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.

## Reason for recall

In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of 3 hours and up to 24 hours, which may lead to delays in carrying out the subsequent analysis tests.

## Distribution

Worldwide Distribution: US (nationwide) to states of:  AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK,OR, PA, RI, TN, TX, VA, VT, WA and WI; and countries of: Canada and Australia.

## Key facts

- **Recall number:** Z-0489-2019
- **Recalling firm:** Merck Millipore Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-14
- **Report date:** 2018-11-28
- **Termination date:** 2021-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** County Cork, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2019

## Citation

> AI Analytics. FDA recall Z-0489-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0489-2019. Source: US FDA. Licensed CC0.

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