Merck Millipore Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0489-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 14, 2018

Date Posted: November 28, 2018

Recall Number: Z-0489-2019

Event ID: 81122

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.

Status: Terminated

Product Quantity: 1360 units

Code Information:

Lot/Unit Numbers 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) 9031 (Model: Minicon B-15): R7HA21782, R7HA25141, R7HA25142, R7HA25143, R7JA25144, R7JA29966, R7KA29967, R7KA37204, R7KA47996, R7KA47998, R7MA62669, R7MA62670, R7MA62671, R7MA70413, R7MA73041, R7NA73042, R7NA76185, R7NA76186, R7NA84720, R7PA90587, R7PA90588, R7SA03064, R8AA13174, R8AA13175, R8AA13176, R8AA17729 9051 (Model: Minicon CS-15): R7HA32882, R7HA33739, R7HA33741, R7MA53165, R7MA53166, R8AA13177

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated