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Lower risk Medical device recall · FDA · Published June 5, 2019

Qiagen Filter-Tips Recall: Leaking Tips with QIAsymphony SP/AS

Qiagen recalls Filter-Tips (1500 ul) used with QIAsymphony SP/AS instruments due to leaking tips in some lots. Affected lots: 0605020019 and 0605020020. Stop using if leaking.

🇺🇸 FDA recall #Z-2088-2019Medical deviceQiagen ›
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Recalling firmQiagen Sciences LLC19300 Germantown Rd · Germantown, MD 20874-1415
✎ GovInfoNow plain-language explainer

Qiagen is recalling Filter-Tips (1500 ul) that come in kits with 1024 tips. Some of these tips leak when used with QIAsymphony SP/AS instruments, which could lead to contamination or inaccurate results. If you have the affected lots, stop using them immediately. Read more at govinfonow.com/recall/67772-qiagen-filter-tips-recall-leaking-tips-with-qiasymphony-sp-as.

Source Summary by GovInfoNow · govinfonow.com/recall/67772-qiagen-filter-tips-recall-leaking-tips-with-qiasymphony-sp-as · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2088-2019

Cite this page

“Qiagen Filter-Tips Recall: Leaking Tips with QIAsymphony SP/AS.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67772-qiagen-filter-tips-recall-leaking-tips-with-qiasymphony-sp-as. Based on FDA recall #Z-2088-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2088-2019%22&limit=1).

The FDA announced on June 5, 2019, that Qiagen Sciences LLC recalled Filter-Tips used with QIAGEN QIAsymphony SP/AS Instruments due to leaking tips. The agency classified the recall as Class I.

How to tell if you have it

  • Brand: Qiagen
  • Product: Filter-Tips, 1500 ul (1024 tips/kitbox)
  • REF: 997024
  • Lot Numbers: 0605020019 and 0605020020
  • Quantity: 1240 Kits

The hazard

Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301).

Context

GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Recent Qiagen recalls include a March 12, 2025 recall for faulty QIAstat-Dx Respiratory Panel Plus cartridges and a June 3, 2024 recall for the QIAcube Connect MDx Heater Shaker Module. Other recent recalls of similar products include Stryker AHTO Tube Set Leaking During Use (June 8, 2026) and Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026).

How to tell if you have this one

Check the lot numbers on your Filter-Tips kit: 0605020019 and 0605020020. These tips are used with Qiagen QIAsymphony SP/AS instruments and are part of the REF 997024 kit.

  • Brand
    Qiagen
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Leaking Tips

    Inspect your Filter-Tips for leaks when used with QIAsymphony SP/AS instruments. If leaking, stop using them immediately.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Jun 5, 201912. FDA classified it Class I: Aug 1, 201923. Published in FDA’s Enforcement Report: Aug 7, 201934. FDA terminated the recall: Aug 28, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2088-2019 (June 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2088-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA