FDA-Device2024-04-17Class II
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
Qiagen Sciences LLC
Hazard
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
Sold states
Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH
Affected count
168 units: 38 units US; 130 units OUS
Manufactured in
19300 Germantown Rd, N/A, Germantown, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1508-2024Don't want to check this manually?
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