Class 2 Device Recall Minicon Clinical Sample Concentrators

• Date Initiated by Firm: May 14, 2018
• Create Date: November 20, 2018
• Recall Status: Terminated on August 05, 2021
• Recall Number: Z-0489-2019
• Recall Event ID: 81122
• Product Classification: Clinical sample concentrator - Product Code JJH
• 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.
• 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
• Recalling Firm/ Manufacturer: Merck Millipore Ltd.; Tullagreen Carrigtwohill; County Cork Ireland
• For Additional Information Contact: 21-4532455
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.