Z-0200-2015Class II

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

Name: Z-0200-2015 Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for...
Creator: Remel Inc
Published: 2014-10-17
License: https://open.fda.gov/license/

Remel Inc / initiated 2014-10-17 / Terminated

FDA source

Remel Inc began a recall of Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella on 2014-10-17. FDA classified it as Class II and gives the reason as "Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0200-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Posted: 2014-11-10
Terminated: 2017-02-13
Recalling firm: Remel Inc
Product: Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
Product code: JSK Supplement, Culture Media
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.
FDA root cause: Under Investigation by firm
Action: Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.
Quantity in commerce: 16/10/100 ml, vial, pkgs
Distribution: Distributed in the states of ND, VT and TX.
Product codes and lots: Lot Number: 1451506 Expiration: 26Feb2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0200-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0200-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-10

Product code JSK

K831469Class ILegionella Cye Agar Base & Bcye SupplOxoid U.S.A., Inc. / cleared 1983-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)