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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Recall Number Z-1177-2014
Classification Class II
Code Info Serial number range: AS 180-00001 to AS 180-00476
Product Distributed Qty 471 instruments
Reason For Recall 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.

Event Detail

Event Id 67463
Product Type Devices
Status Ongoing
Recalling Firm Biomerieux Inc
City Hazelwood
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-10
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern 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.
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