Z-1232-2015Class II

Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm...

Name: Z-1232-2015 Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm...
Creator: Remel Inc
Published: 2015-02-05
License: https://open.fda.gov/license/

Remel Inc / initiated 2015-02-05 / Terminated

FDA source

Remel Inc began a recall of Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke... on 2015-02-05. FDA classified it as Class II and gives the reason as "Use of the product may not provide adequate recovery and could 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-1232-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Posted: 2015-03-02
Terminated: 2017-02-13
Recalling firm: Remel Inc
Product: Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
Product code: JSK Supplement, Culture Media
Reason for recall: Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
FDA root cause: Under Investigation by firm
Action: ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the consignees of the recall and the associated risk of false negative identification of Legionella pneumophila. The consignees were instructed to notify any personnel who need to be aware of the potential for false negative id. of Legionella spp. Further, the consignees were instructed to discard any affected product remaining in their inventory and review all results reported using the recalled lot. The recalling firm requested the consignees complete and return the Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. If the affected lot was further distributed, the consignees were instructed to notify those entities of the recall and provide a copy of the recall notification letter. If you have any questions, please contact our Technical Services Department at 800.255.6730 (US) or 913.888.0939 ( International)
Quantity in commerce: 24 packs (10 x 100 ml vials)
Distribution: US Distribution to the states of : MI, ND, SC, TN, and TX.
Product codes and lots: Lot No. 1545171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1232-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1232-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

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)