Recall Z-0489-2019— Merck Millipore Ltd.
Class II · Terminated
Class II FDA medical device recall by Merck Millipore Ltd., initiated 2018-05-14, terminated 2021-08-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Merck Millipore Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-14
- Terminated
- 2021-08-05
- Firm location
- County Cork, N/A, Ireland
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.