| Class 2 Device Recall PREVI Isola System | |
Date Initiated by Firm | August 28, 2012 |
Date Posted | October 09, 2012 |
Recall Status1 |
Terminated 3 on September 04, 2014 |
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
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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 MO 63042-2320
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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 | 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 |
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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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