Reported Aug 28, 2019 · Ongoing

QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed…

Qiagen Sciences LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415

Is this the product you have?

  • 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 Number9001297
  • Product UsageThe 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
Lot codes and dates
  • Software 5.0.3
  • Serial Numbers

    389 of 389 codes

    • 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
Amount recalled
417

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.