Z-0801-2013Class II

The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium...

Name: Z-0801-2013 The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium...
Creator: Remel Inc
Published: 2012-10-10
License: https://open.fda.gov/license/

Remel Inc / initiated 2012-10-10 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and... on 2012-10-10. FDA classified it as Class II and gives the reason as "The product may contain low level microbial contamination which could result in incorrect results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0801-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Posted: 2013-02-11
Terminated: 2013-06-04
Recalling firm: Remel Inc
Product: The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
Product code: JSK Supplement, Culture Media
Reason for recall: The product may contain low level microbial contamination which could result in incorrect results.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization. The firm request the information form be faxed back confirming receipt of notice. For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144.
Quantity in commerce: 10 units
Distribution: Distribution included the states of IL, IN and MI.
Product codes and lots: Lot 1175209

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0801-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0801-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-11

Product code JSK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)