Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 — Class II medical device recall Z-0489-2019
Terminated recall by Merck Millipore Ltd., reported 2018-11-28, distributed nationwide. In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentr
| Recall number | Z-0489-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merck Millipore Ltd., County Cork, N/A, Ireland |
| Recall initiated | 2018-05-14 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2021-08-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 1,360 units |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0489-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.