RegWardenFDA facility compliance records
Recall

Class II — QIAGEN

Recalling firmQIAGEN, GmbH
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonUnderfilled reagent well that could lead to incorrect results
ProductEZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Quantity287 pcs
DistributionDomestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
Initiated2018-05-28
Classified2018-08-02
Terminated2019-04-05
Recall numberZ-2596-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — QIAGEN (Z-2596-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80430/

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