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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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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
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.

Product Detail

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