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.
Reported: October 17, 2012 Initiated: August 28, 2012 #Z-0023-2013
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.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 350 systems
- Distribution
- 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.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomerieux Inc. Units affected: 350 systems.
Why was this product recalled? ▼
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0023-2013.
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