Z-0230-2015Class III

Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique...

Name: Z-0230-2015 Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique...
Creator: Biomerieux
Published: 2014-10-16
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2014-10-16 / Terminated / root cause: labeling and UDI

FDA source

Biomerieux began a recall of Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of... on 2014-10-16. FDA classified it as Class III and gives the reason as "The products have a wrong expiration date on their labeling, 5 years instead of 2 years". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0230-2015
Classification: Class III
Status: Terminated
Initiated: 2014-10-16
Posted: 2014-11-19
Terminated: 2017-11-30
Recalling firm: bioMerieux, Inc.
Product: Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Consignees of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on October 16th, 2014. Additionally, the bioMrieux United States subsidiary notified US consignees of the FSCA notification via FedEx on October 23rd, 2014.
Quantity in commerce: 652 devices
Distribution: Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.
Product codes and lots: Ref #537500, Lot #1003160540, Right Expiry date: 27-APR-2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0230-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0230-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-19
Z-0231-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-19
Z-0232-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-19
Z-0233-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-19
Z-0234-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-19

Product code JWY

K121002Class IIEtest CeftarolinebioMerieux, Inc. / cleared 2012-10-12

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)