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Class 2 Device Recall bioMerieux PREVI Isola System |
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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
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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
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For Additional Information Contact |
Ryan LeMelle 314-731-8526
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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.
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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
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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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