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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00659-1
Product Name/Description EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD)

Catalogue Number: 62724

Lot Numbers: 160017650, 160017770 and 160020069

Corresponding Reagent Cartridge: REAG CART VIRUS (RCV)

Reagent Cartridge Lot Number: 160011000

ARTG Number: 211651
(Qiagen Pty Ltd - General laboratory reagent and consumables IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/05/2018
Responsible Entity Qiagen Pty Ltd
Reason/Issue Qiagen have identified that the kit lots160017650, 160017770, and 160020069 contain a non-conforming EZ1 DSP virus Reagent Cartridge LOT (REG CART VIRUS LOT160011000). In the affected Reagent Cartridges, the Proteinase K Solution in well 10 is missing, i.e. well 10 is empty.
At a maximum, eight of the 48 Reagent Cartridges in one kit are affected. All affected Reagent Cartridges are on Position 6 within the clamshell box.
Recall Action Recall
Recall Action Instructions Qiagen is advising users to immediately discontinue use and dispose of kits with lots 160017650, 160017770, 160020069, and/or REAG CART LOT 160011000. Users should contact Qiagen Technical Service to arrange replacement.

This action has been closed out on 10/07/2019
Contact Information 1800 243 800 - Qiagen