Recall archive / FDA device enforcement
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic... — FDA record Z-1508-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 168 units: 38 units US; 130 units OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1508-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 P1222014M P0223011M P0923041M P0722010M P1022070M P0722006M P0722020M P0123037M P1123024M P0523117M P1123011M P0523108M P0923039M P0523096M P0323026M P0523107M P0722012M P0722008M P0923040M P0923038M P0722019M P0223013M P1123009M P0523100M P1123005M P0323025M P0223015M P0123077M P0223018M P1123004M P0722015M P0123079M P1123034M P0823041M P0523099M P0722005M P1123020M P1222011M P0123078M P0923037M P0323033M P0722009M P0523105M P0722018M P0523113M P0523103M P0722001M P0722017M P0523101M P0722014M P0323032M P0823045M P0722004M P1222038M P0523102M P1022072M P0223024M P0123036M P0523109M P0823048M P1123006M P0623002M P0323030M P0722016M P0823046M P1222013M P0823003M P0722002M P0722013M P0423041M P0423042M P0423055M |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 17, 2024
- Recall initiation date
- Mar 4, 2024
- Center classification date
- Apr 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.