EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular…
Medical device recall Z-1508-2024. Published in FDA’s Enforcement Report on Apr 17, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 17, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 168 units: 38 units US; 130 units OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
168 units: 38 units US; 130 units OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 04053228040576 US: P0722011M P0123035M P0323027M P0623016M P0823004M P0823051M P0523120M P0323035M P0423054M P0523114M P0823039M P0623013M P0323028M P0722022M P0223019M P1222015M P1222040M P0523110M P0523097M P0623014M P1022066M…
Every code shown here, 1,709 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 4, 2024.
- FDA classified it on Apr 10, 2024.
- FDA’s Enforcement Report published it on Apr 17, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Qiagen Sciences LLC, of Germantown, MD.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.