FDAFDA · Food and drugs·Recall number Z-1177-2014
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Published March 19, 2014 · Recall initiated: February 10, 2014
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 firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.
- Lot
- Serial number range: AS 180-00001 to AS 180-00476
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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