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Recall Observatory FDA recall evidence

Device product

Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.

Z-0200-2015

October 17, 2014

Class II

Product summary

Firm
Remel Inc
Event
Event 69521
Status
Terminated
Classification
Class II
Quantity
16/10/100 ml, vial, pkgs
Official record key
device-enforcement:Z-0200-2015

Official wording

Reason: Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.

Code information: Lot Number: 1451506 Expiration: 26Feb2016

Distribution pattern: Distributed in the states of ND, VT and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.