FDA recall Z-0489-2019

Merck Millipore Ltd. · Class II · device

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

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

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