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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

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ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Catalog Number 07P60-77
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2020
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 was included. Additional patient details are not available.
 
Event Description
The customer reported a (b)(6) alinity i syphilis tp result on one patient. Results provided: (b)(6), architect
=
(b)(6), previous (b)(6) antibody test was (b)(6) along with a (b)(6) test, elisa test is (b)(6). No impact to patient management was reported.
 
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Brand NameALINITY I SYPHILIS TP REAGENT KIT
Type of DeviceENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key10792024
MDR Text Key214800735
Report Number3002809144-2020-01088
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K153730
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,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2020
Device Catalogue Number07P60-77
Device Lot Number11057BE01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/05/2020 Patient Sequence Number: 1
Treatment
ALNTY I PROCESSING MODU, 03R65-01, AI03097
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