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U.S. Department of Health and Human Services

Class 2 Device Recall PREVI Isola System

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 Class 2 Recall
PREVI Isola System
see related information
Date Posted October 09, 2012
Recall Status1 Open
Recall Number Z-0023-2013
Recall Event ID 63019
Product Classification Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use - Product Code LXG
Product 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.
Code Information Serial numbers AS180-00001 to AS180-00376.
Recalling Firm/
Manufacturer
Biomerieux Inc
595 Anglum Rd
Hazelwood, Missouri 63042-2320
For Additional Information Contact Ryan LeMelle
314-731-8582
Manufacturer Reason
for Recall
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice.
Quantity in Commerce 350 systems
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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