Recall Z-0023-2013— Biomerieux Inc

Name: FDA recall Z-0023-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-28

Class II · Terminated

Class II FDA medical device recall by Biomerieux Inc, initiated 2012-08-28, terminated 2014-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.. Reason: The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result..

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Terminated
Initiated: 2012-08-28
Terminated: 2014-09-04
Firm location: Hazelwood, MO, United States

Product description

PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Reason for recall

The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.

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