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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

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.
Recall Number Z-0023-2013
Classification Class II
Code Info Serial numbers AS180-00001 to AS180-00376.
Product Distributed Qty 350 systems
Reason For Recall The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.

Event Detail

Event Id 63019
Product Type Devices
Status Ongoing
Recalling Firm Biomerieux Inc
City Hazelwood
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of Consignee or Public Letter
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.
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