BioMerieux SA: Medical Device Recall in 2015 - (Recall #: Z-1947-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

Product Classification:

Class II

Date Initiated: June 12, 2015

Date Posted: July 8, 2015

Recall Number: Z-1947-2015

Event ID: 71475

Reason for Recall:

QC results were out of range resulting in false resistant strains.

Status: Terminated

Product Quantity: 674

Code Information:

1002774320, 1002377890, 1002590470, 1002775330, 1002379610

Distribution Pattern:

Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated