FDAFDA · Food and drugs·Recall number Z-0023-2013
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.
Published October 17, 2012 · Recall initiated: August 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- 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.
- Lot
- Serial numbers AS180-00001 to AS180-00376.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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