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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
Catalog Number 07P60-22
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2020
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: sample id is (b)(6). All available patient information has been included. No additional patient details are available. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported falsely (b)(6) result when processing on the alinity i. The following data was provided for sid (b)(6): on (b)(6) 2020, (b)(6), and retests on (b)(6) 2020 was (b)(6), and on (b)(6) 2020, repeated in duplicate were (b)(6). The fta abs ifi test performed was (b)(6). No impact to patient management was reported.
 
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Brand NameALINITY I SYPHILIS TP REAGENT KIT
Type of DeviceSYPHILIS TP
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 Key9953445
MDR Text Key187541531
Report Number3002809144-2020-00318
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeBR
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 06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/25/2020
Device Catalogue Number07P60-22
Device Lot Number04152BE00
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 Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2019
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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