Recall Z-0489-2019 ยท JJH Clinical Sample Concentrator
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.
| Date | May 14, 2018 |
| Status | Terminated |
| 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 n |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.