Class 2 Device Recall bioMerieux PREVI Isola System

• Date Initiated by Firm: February 10, 2014
• Date Posted: March 12, 2014
• Recall Status: Terminated on March 16, 2017
• Recall Number: Z-1177-2014
• Recall Event ID: 67463
• Product Classification: General Purpose, microbiology, diagnostic Medical Device - Product Code LIB
• Product: bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
• Code Information: Serial number range: AS 180-00001 to AS 180-00476
• FEI Number: 1950204
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: Ryan LeMelle; 314-731-8526
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: The firm sent a recall notification letter to all of their consignees on 2/10/2014.
• Quantity in Commerce: 471 instruments
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.