FDA Device recall Z-1508-2024
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biol…
- FDA Device
- Class II
- ongoing
- Published 2024-04-17
On 2024-04-17 the FDA classified a Class II recall of EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biol… by Qiagen Sciences, citing insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1508-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-04 |
| Published | 2024-04-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
Product
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
Reason
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
Identifiers
| code_info | GTIN: 04053228040576 US: P0722011M P0123035M P0323027M P0623016M P0823004M P0823051M P0523120M P0323035M P0423054M P05…GTIN: 04053228040576 US: P0722011M P0123035M P0323027M P0623016M P0823004M P0823051M P0523120M P0323035M P0423054M P0523114M P0823039M P0623013M P0323028M P0722022M P0223019M P1222015M P1222040M P0523110M P0523097M P0623014M P1022066M P1022069M P1022074M P0523106M P0423039M P1123016M P0423056M P0523098M P0823050M P0623008M P0223014M P0323038M P0123038M P0623015M P1022065M P0623017M P0722007M P0523118M ROW: P0823002M P0223022M P1022073M P0923045M P1123027M P1222012M P0223012M P0123082M P0823038M P0722003M P0523116M P0523112M P0523119M P0523111M P1123003M P1123001M P1123031M P1022067M P0523104M P1222039M P0923042M P1123033M P0923050M P0323034M P0223008M P0623012M P0223010M P0623005M P0623004M P0623001M P0623010M P0223016M P0223017M P0623011M P0623007M P0223023M P0223026M P0223009M P0123081M P0423040M P1123025M P1022064M P0323029M P0223021M P0523115M P1123023M P0323024M P1123026M P0722023M P0823049M P0323036M P0923044M P0823042M P0423058M P0623006M P0823052M P0623003M P0323031M P122201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1508-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.