FDA Device recall Z-0489-2019
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentr…
- FDA Device
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentr… by Merck Millipore, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0489-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-14 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merck Millipore |
| Distribution | US |
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.
Identifiers
| code_info | Lot/Unit Numbers 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) 9031 (Model: Minicon B-15): R7HA21782, R…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2019%22
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