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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX S.A. ID COLOR CATALASE 2X5 ML

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BIOMERIEUX S.A. ID COLOR CATALASE 2X5 ML Back to Search Results
Catalog Number 55561
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer from germany notified biomérieux of false positive results in association with id color catalase (ref. 55561, lot 1007568120). The customer tested atcc® 29212¿ enterococcus faecalis and an unknown number of patient enterococcus faecalis and streptococci strains with lot 1007568120. The number of patient strains impacted was not provided. The customer stated the false positive catalase result caused the incorrect vitek® 2 cards to be used for antibiotic susceptibility testing (ast) leading to a delay in obtaining ast results. The customer also tested the isolates using lot 1007205060; false positive results were also obtained. There is no indication or report from the laboratory that the false positive result led to any adverse event related to any patient's state of health. Biomérieux has initiated an internal investigation.
 
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Brand NameID COLOR CATALASE 2X5 ML
Type of DeviceID COLOR CATALASE 2X5 ML
Manufacturer (Section D)
BIOMERIEUX S.A.
5 rue des aqueducs
craponne 69290
FR 69290
Manufacturer (Section G)
BIOMERIEUX S.A.
5, rue des aqueducs
craponne 69290
FR 69290
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key10678878
MDR Text Key246421111
Report Number9615755-2020-00022
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeGM
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 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/05/2021
Device Catalogue Number55561
Device Lot Number1007568120
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 Received10/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2019
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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