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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA API® LISTERIA 10STRIPS+10MEDIA

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BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA API® LISTERIA 10STRIPS+10MEDIA Back to Search Results
Model Number 10300
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of misidentifications of listeria monocytogenes when testing two (2) strains with api® listeria 10strips+10media (ref 10300, lot 1007942830). The listeria monocytogenes strains included one (1) isolated from food samples and one (1) internal l. Monocytogenes qc strain (atcc® 13932¿). Api obtained listeria welshimeri and listeria innocua as significant taxon for the strain isolated from food samples and listeria welshimeri as significant taxon for the qc strain. The expected identification of listeria monocytogenes was confirmed by a reference lab with pcr and sero-type identification. There is no patient involved as food and qc strains are impacted. A biomérieux internal investigation will be initiated.
 
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Brand NameAPI LISTERIA 10STRIPS+10MEDIA
Type of DeviceAPI® LISTERIA 10STRIPS+10MEDIA
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key10398218
MDR Text Key205481331
Report Number9615754-2020-00135
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
C1 EXEMPT
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 08/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/05/2021
Device Model Number10300
Device Catalogue Number10300
Device Lot Number1007942830
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 Received08/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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