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Recall Observatory FDA recall evidence

Device product

EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

Z-2596-2018

May 28, 2018

Class II

Product summary

Firm
QIAGEN
Event
Event 80430
Status
Terminated
Classification
Class II
Quantity
287 pcs
Official record key
device-enforcement:Z-2596-2018

Official wording

Reason: Underfilled reagent well that could lead to incorrect results

Code information: UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19

Distribution pattern: Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Underfilled reagent well that could lead to incorrect results