Z-1112-2014Class II

Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized...

Name: Z-1112-2014 Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized...
Creator: Remel Inc
Published: 2014-01-24
License: https://open.fda.gov/license/

Remel Inc / initiated 2014-01-24 / Terminated / root cause: sterility

FDA source

Remel Inc began a recall of Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd... on 2014-01-24. FDA classified it as Class II and gives the reason as "The product may contain high levels of microbial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1112-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Posted: 2014-02-26
Terminated: 2014-07-23
Recalling firm: Remel Inc
Product: Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.
Product code: JSK Supplement, Culture Media
Reason for recall: The product may contain high levels of microbial contamination
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: Thermo Fisher sent an Urgent Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please notify any personnel who need to be aware of the potential for false presumptive Legionella spp. identification or masking of the recovery/isolation of Legionella spp. Review your inventory for the affected product and discard it. You should review results reported using these lots and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If you have further distributed these product lots, please contact those entities, advise them of the situation and provide them with a copy of this letter. You should insert your contact information, email, and fax numbers in the acknowledgement form and request that they return it to you. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in commerce: 44/10/500-ml. vial boxes
Distribution: US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.
Product codes and lots: Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1112-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1112-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26

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)