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Recall Observatory FDA recall evidence

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.

Z-0489-2019

May 14, 2018

Class II

Product summary

Firm
Merck Millipore Ltd.
Event
Event 81122
Status
Terminated
Classification
Class II
Quantity
1360 units
Official record key
device-enforcement:Z-0489-2019

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.