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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT

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ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT Back to Search Results
Model Number N/A
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. All available patient information is included. Additional patient details are not available. This report is being filed on an international product, list number 07p60-22 that has a similar product distributed in the us, list number 07p60-21.
 
Event Description
The customer reported false reactive alinity i (b)(6) assay results for one blood donor. The customer provided: donor sample initial
=
11. 49 s/co, repeat 11. 65 s/co, 11. 77 s/co (ref range: < 0. 10 s/co
=
nonreactive; equal to or > 1. 00 s/co reactive). The sample was tested with an immunoblot and an alternative chemiluminescence test and was stated to be nonreactive with both. There was no impact to patient management reported.
 
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Brand NameALINITY I SYPHILIS TP REAGENT KIT
Type of DeviceSYPHILIS
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key10263434
MDR Text Key230623377
Report Number3002809144-2020-00630
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2020
Device Model NumberN/A
Device Catalogue Number07P60-22
Device Lot Number11054BE00
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 Received08/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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