QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is…
Medical device recall Z-2319-2019. Published in FDA’s Enforcement Report on Aug 28, 2019.
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 Aug 28, 2019. 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
- 417 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?
QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument
417, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software 5.0.3 Serial Numbers: 5786 13184 30000 34450 34886 35214 35455 35510 5943 13195 34023 34457 34887 35222 35456 35514 6037 13275 34040 34464 34891 35224 35457 35519 6263 13486 34045 34468 34892 35226 35458 35522 6325 13592 34068…
Every code shown here, 1,996 characters
Software 5.0.3 Serial Numbers: 5786 13184 30000 34450 34886 35214 35455 35510 5943 13195 34023 34457 34887 35222 35456 35514 6037 13275 34040 34464 34891 35224 35457 35519 6263 13486 34045 34468 34892 35226 35458 35522 6325 13592 34068 34473 34893 35231 35459 35524 6529 13635 34907 34477 34894 35241 35460 35525 6531 13640 34080 34495 34896 35245 35462 35526 6828 13648 34081 34496 34897 35259 35463 35529 7188 13654 34083 34504 34901 35265 35464 35530 7232 13755 34086 34507 34902 35278 35465 35532 7295 13773 34112 34525 34701 35279 35466 35537 7297 13777 34116 34555 34914 35287 35467 35538 7340 13797 34123 34557 34923 35312 35468 35542 7349 13813 34124 34562 34931 35322 35469 35544 7409 13841 34129 34567 34951 35335 35471 35545 7432 13858 34143 34571 34977 35338 35472 35547 7480 13862 34152 34580 34981 35344 35473 35548 7725 13874 34153 34582 34986 35352 35474 35549 7973 13886 34161 34588 34988 35360 35475 35550 8049 13904 34181 34589 34366 34076 35476 35557 8052 13948 34184 34596 35001 35381 35477 35558 10109 14021 34192 34597 35011 35382 35478 35559 10198 14108 34204 34603 35013 35384 35479 35560 10389 14153 34221 34610 35014 35386 35497 35561 10630 14178 34229 34622 35015 35387 35481 35564 11177 14207 34237 34628 35024 35398 35482 35565 11392 14209 34245 34631 35030 35399 35483 35566 11417 14219 34247 34637 35033 35406 35484 35567 11431 14262 34252 34644 35042 35408 35485 35568 11590 14356 34265 34646 35045 35411 35486 35569 11609 14564 34268 34649 35061 35412 35487 35570 11938 14617 34269 34666 35070 35435 35488 35571 12010 14629 34281 34695 35075 35436 35489 35572 12052 14676 34297 34396 35079 35438 35490 35573 12053 14678 34322 34719 35083 35439 35491 35574 12106 14689 34338 34727 35086 35440 35492 35575 12175 14697 34342 34732 35094 35441 35493 35576 12203 14698 34343 34757 35097 35442 35495 35577 12275 14706 34349 34765 35115 35443 35496 47000 12304 14748 35362 34771 35118 35444 35480 12308 14764 34373 34787 35129 35445 35498 12435 14840 34392 34802 35132…
FDA’s list runs to 2,343 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.
Worldwide Distribution - US Nationwide Foreign: Algeria Australia Austria Azerbaijan Belgium Brazil Canada China Czech Republic Denmark Finland France Germany Greece India Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Mexico Netherlands Norway Pakistan Poland Republic of Korea Russian Federation Singapore South Africa Spain Sweden Switzerland Thailand Turkey United Kingdom
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 Jul 2, 2019.
- FDA classified it on Aug 21, 2019.
- FDA’s Enforcement Report published it on Aug 28, 2019.
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 2,343 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
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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.