Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224…
Medical device recall Z-1504-2025. Published in FDA’s Enforcement Report on Apr 9, 2025.
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 9, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 12 states named in where it went
- 445 units 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?
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
445 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 332168961 332168962 332168963 332168964 332168972 332168978 332168979 332168980 332168990 332168996 332169005 332169012 332169013 332169015 332169016…
Every code shown here, 1,992 characters
REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 332168961 332168962 332168963 332168964 332168972 332168978 332168979 332168980 332168990 332168996 332169005 332169012 332169013 332169015 332169016 332169021 332169022 332169023 332169024 332169031 332169032 332169033 332169034 332169039 332169040 332169041 332169042 332169047 332169048 332169049 332169050 332169055 332169056 332169057 332169060 332169065 332169066 332169073 332169074 332169083 332169084 332169085 332169086 332169091 332169092 332169093 332169094 332169099 332169101 332169102 332169107 332169108 332169109 332169110 332169115 332169116 332169117 332169118 332169123 332169125 332169126 332169131 332169132 332169133 332169134 332169139 332169140 332169141 332169142 332169147 332169148 332169149 332169150 332169155 332169156 332169157 332169158 332169163 332169164 332169165 332169166 332169171 332169172 332169173 332169174 332169180 332169181 332169182 332169187 332169188 332169189 332169190 332169195 332169196 332169197 332169198 332169203 332169204 332169205 332169206 332169212 332169213 332169214 332169216 332169221 332169222 332169223 332169224 332169229 332169230 332169231 332169232 332169238 332169239 332169240 332169241 332169246 332169247 332169248 332169249 332169255 332169256 332169257 332169262 332169263 332169264 332169265 332169271 332169272 332169273 332169279 332169280 332169282 332169287 332169288 332169289 332169290 332169295 332169296 332169297 332169298 332169303 332169315 332169320 332169321 332169322 332169323 332169328 332169329 332169330 332169331 332169336 332169337 332169338 332169339 332169344 332169345 332169346 332169347 332169354 332169355 332169360 332169361 332169362 332169365 332169368 332169369 332169370 332169371 332169376 332169377 332169378 332169379 332169384 332169385 332169386 332169387 332169392 332169393 332169394 332169395 332169401 332169403 332169410 332169412 332169413 332169418 332169420 332169427 332169428 332169429…
FDA’s list runs to 2,081 characters. The first part is shown; the rest is on FDA’s record.
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.
US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
The states and territories these words name
- Alabama
- California
- District of Columbia
- Florida
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maine
- Minnesota
- New York
- Texas
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 12, 2025.
- FDA classified it on Mar 31, 2025.
- FDA’s Enforcement Report published it on Apr 9, 2025.
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.”
- FDA’s list of codes runs to 2,081 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
-
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.