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Terminated

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

FDA Recall Z-0200-2015 · Posted 2014-11-10

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJSK
Date Initiated2014-10-17
Date Terminated2017-02-13
Product Quantity16/10/100 ml, vial, pkgs

Reason for Recall

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

Firm Action

Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed in the states of ND, VT and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K831469LEGIONELLA CYE AGAR BASE & BCYE SUPPLOxoid U.S.A., Inc. · 1983-06-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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