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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SCARBOROUGH, INC. BINAXNOW INFLUENZA A B CARD 2 RAPID FLU TEST

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ALERE SCARBOROUGH, INC. BINAXNOW INFLUENZA A B CARD 2 RAPID FLU TEST Back to Search Results
Model Number 575-000
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2020
Event Type  malfunction  
Event Description
No solution in elution vial to run influenza test. Elution vial was empty and cap was intact prior to opening. Manufacturer response for rapid flu test, binax now influenza a&b card 2 (per site reporter). Event reported to usproductsupport@abbott. Com. Alere case #(b)(4). Response received from alere technical services. No further feedback or instructions received.
 
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Brand NameBINAXNOW INFLUENZA A B CARD 2
Type of DeviceRAPID FLU TEST
Manufacturer (Section D)
ALERE SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
MDR Report Key10046508
MDR Text Key190625661
Report Number10046508
Device Sequence Number1
Product Code PSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2020,04/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number575-000
Device Catalogue Number575-000
Device Lot Number113348
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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