Z-0023-2013 Class II Terminated
FDA device recall Z-0023-2013 was initiated by Biomerieux Inc on Aug 28, 2012 and is designated Class II. Reason for recall: The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result. The recall status is terminated (terminated Sep 4, 2014). Affected quantity: 350 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2012
- Initiation Date
- Aug 28, 2012
- Termination Date
- Sep 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 350 systems
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.
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.
Code Information
Serial numbers AS180-00001 to AS180-00376.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0023-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026