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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 07P60-74
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information: no further patient information was provided by the customer. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed (b)(6) alinity (b)(6) results on one patient. The results were provided: on (b)(6) 2020 sid (b)(6) initial (b)(6) result(b)(6)/ repeated on colloidal gold method result
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(b)(6)/repeated on other i2sr analyzer (b)(6) result
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(b)(6)/ inco"s new colloidal gold result
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(b)(6) /rpr result
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(b)(6), tppa result
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(b)(6). There was no reported impact to patient management.
 
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Brand NameALINITY I SYPHILIS TP REAGENT KIT
Type of DeviceALINITY I SYPHILIS 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 Key9985817
MDR Text Key188735249
Report Number3002809144-2020-00338
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeCH
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 06/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/27/2020
Device Catalogue Number07P60-74
Device Lot Number10030BE01
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 Received06/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
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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