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U.S. Department of Health and Human Services

Class 2 Device Recall bioMerieux PREVI Isola System

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  Class 2 Device Recall bioMerieux PREVI Isola System see related information
Date Initiated by Firm February 10, 2014
Date Posted March 12, 2014
Recall Status1 Terminated 3 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
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 2		 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.
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