Drug recall
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model…
FDA recall event 81122 · Class II · Merck Millipore Ltd.
Key facts
| Event ID | 81122 |
|---|---|
| Recall numbers | Z-0489-2019 |
| Recalling firm | Merck Millipore Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 14, 2018 |
| Report date | Nov 28, 2018 |
| Termination date | Aug 5, 2021 |
| City | County Cork |
| Country | Ireland |
| FEI number | 1000532580 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: