Recall Z-1947-2015— BioMerieux SA

Name: FDA recall Z-1947-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-12

Class II · Terminated

Class II FDA medical device recall by BioMerieux SA, initiated 2015-06-12, terminated 2017-08-01. It names one FDA 510(k) clearance: K981137. Product: Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.. Reason: QC results were out of range resulting in false resistant strains..

Recalling firm: BioMerieux SA
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Terminated: 2017-08-01
Firm location: Marcy L'Etoile, France

510(k) clearances named in this recall

1 on FDA's record

K981137 — ETEST CEFOTAXIMEAb Biodisk·cleared 1998-06-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.