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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGG

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BIOMERIEUX SA VIDAS® LYME IGG Back to Search Results
Catalog Number 30320
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in the (b)(6) notified biomérieux of obtaining discrepant results while performing quality control (qc) testing with the vidas® lyme igg 60 tests (reference 30320, lot 1007086220). Global customer service reviewed the data and confirmed the customer obtained a potential falsely underestimated result with this lot. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. Biomérieux has initiated an internal investigation. Note: reference 30320 is not registered in the united states. The u. S. Similar device is product reference 417401 (vidas lyme igg ii).
 
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Brand NameVIDAS® LYME IGG
Type of DeviceVIDAS® LYME IGG
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280,
FR
Manufacturer (Section G)
BIOMERIEUX, INC.
595 anglum road
hazelwood MO 63042
Manufacturer Contact
jeff scanlan
595 anglum road
hazelwood, MO 63042
3147318694
MDR Report Key9078076
MDR Text Key218748964
Report Number8020790-2019-00055
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K122986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/17/2020
Device Catalogue Number30320
Device Lot Number1007086220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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