FDAClass IIAugust 8, 2018

EZ1 DSP Virus Kit recall

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

Why was EZ1 DSP Virus Kit recalled?

Underfilled reagent well that could lead to incorrect results

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19

Product
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Recalling firm
QIAGEN
Quantity
287 pcs
Distribution
Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
Recall date
August 8, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls