Biomerieux Inc: Medical Device Recall in 2012 - (Recall #: Z-0023-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 28, 2012

Date Posted: October 17, 2012

Recall Number: Z-0023-2013

Event ID: 63019

Reason for Recall:

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

Status: Terminated

Product Quantity: 350 systems

Code Information:

Serial numbers AS180-00001 to AS180-00376.

Distribution Pattern:

Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated