Home / Recalls / bioMerieux, Inc. / Z-0435-2022

Z-0435-2022 Class II Ongoing

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
January 5, 2022
Initiation Date
September 22, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
One lot

Product Description

VIDAS Estradiol II, REF 30431-01

Reason for Recall

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI 03573026161637, Lot #: 1008757880

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