Merck Millipore Ltd.: 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.

Recall number

Z-0489-2019

Recalling firm

Merck Millipore Ltd.

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.

Status

Terminated

Initiated

2018-05-14

Posted

not on file

Terminated

2021-08-05

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.

Root cause

Process control

Action

On May 14, 2018, the firm sent an "Urgent Field Safety Notice" to customers via email and following up with a hard-copy letter on June 6, 2018 via United States Postal Services. The letter described the product, problem and actions to be taken. The corrective action being taken by the firm is to reduce the shelf life of the device from 12 months to 6 months. The customers are being instructed to immediately examine their inventory to determine if they have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. In addition, if the customer has further distributed this product, please identify its customers and notify them at once of this issue. The notification to their customers should include a copy of this notification and attachment 2 Customers are instructed to please stop use of these lots if older than 6 months and destroy any remaining inventory older than 6 months, and to complete and return the receipt confirmation form to QACorkGroup@merckgroup.com. If you would like more information regarding this notification, please contact us at QACorkGroup@merckgroup.com or go to our website to find the phone number of your local office at www.emdmillipore.com/offices.

Quantity

1360 units

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJH

Firm FEI

1000532580

Firm city

Tullagreen Carrigtwohill County Cork

Firm state

not on file

Firm country

Ireland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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