Z-0578-2015Class II

Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the...

Name: Z-0578-2015 Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the...
Creator: Remel Inc
Published: 2014-11-13
License: https://open.fda.gov/license/

Remel Inc / initiated 2014-11-13 / Terminated

FDA source

Remel Inc began a recall of Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella on 2014-11-13. FDA classified it as Class II and gives the reason as "Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0578-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Posted: 2014-12-12
Terminated: 2015-01-29
Recalling firm: Remel Inc
Product: Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
Product code: JSK Supplement, Culture Media
Reason for recall: Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
FDA root cause: Under Investigation by firm
Action: ThermoFisher sent an Urgent Medical Device Recall letter dated November 13, 2014, to the sole customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative identification of the affected product. Review their inventory for the affected product and discard it. Customers were also instructed to completed the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If further distributed customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730.
Quantity in commerce: 1/10/100 ml/vials/packs
Distribution: Nationwide Distribution to FL
Product codes and lots: Lot number: 1374439, Exp: 31 Aug 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0578-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0578-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-10

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)