Z-0087-2014Class II

chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the...

Name: Z-0087-2014 chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the...
Creator: bioMerieux, Inc.
Published: 2013-09-06
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2013-09-06 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens on 2013-09-06. FDA classified it as Class II and gives the reason as "Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies...". 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-0087-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-06
Posted: 2013-10-28
Terminated: 2014-06-24
Recalling firm: bioMerieux, Inc.
Product: chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
Reason for recall: Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall letters were issued to the US customers by Biomeriux, Durham, NC on 9/6/2013.
Quantity in commerce: 90
Distribution: Nationwide Distribution.
Product codes and lots: Lot 1002234210 and 1002300040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0087-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0087-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)