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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
An industry customer in canada notified biomérieux of a quality control failure in association with api® listeria 10strips+10media (ref. 10300, lot 1007942830) when testing listeria innocua atcc® 33090¿. Lot 1007942830 misidentified listeria innocua atcc 33090 strain as listeria monocytogenes species because of a negative dim reaction. Other atcc® strains below were tested on the impacted lot and obtained the correct results: listeria monocytogenes atcc ®7644¿. Listeria ivanovi atcc® 19119¿. Listeria grayi atcc® 25401¿. Biomerieux customer service has requested the customer to retest listeria innocua atcc® 33090¿on another lot of api strips. Results of repeat testing have not yet been provided. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. Biomerieux will initiate an internal investigation.
 
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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
matthew locus
595 anglum road
hazelwood, MO 63042
MDR Report Key10901450
MDR Text Key219566674
Report Number9615754-2020-00183
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCA
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 01/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
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 Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2020
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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