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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT FREE T3 REAGENT KIT; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

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A.I.D.D LONGFORD ARCHITECT FREE T3 REAGENT KIT; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE Back to Search Results
Model Number 7K63-25
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Date 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
Recall: 3005094123-10/22/18-001-c.Product correction letters were issued on 12oct2018 to all architect total t3 (tt3) and free t3 (ft3) customers, using the i1000sr, i2000, or i2000sr instruments and who received one of the impacted lots.The letter instructed the customers to prevent this interaction by either separating the architect ft3 and/or architect tt3 assays by running these tests on different instruments from the following assays [architect tsh, architect t-uptake, architect hiv ag/ab combo, architect cortisol, architect lh, architect progrp, architect rhtlv-i/ii, architect total psa, architect afp, and architect free psa, architect 25-oh vitamin d], or by performing daily maintenance on the instrument prior to performing batch testing for all ft3 and/or tt3 samples.The mechanism of carryover involves carryover of poly-l-lysine (pll) from other assays into the conjugate dispense step in the ft3 and tt3 assays through adherence of the pipetting probe.
 
Event Description
The customer observed quality controls shifted low for high level for architect free t3 while processing with the reagent lot 14456ui00 there was no reported impact to patient management.
 
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Brand Name
ARCHITECT FREE T3 REAGENT KIT
Type of Device
RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford N39E9 32
EI  N39E932
Manufacturer (Section G)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford N39E9 32
EI   N39E932
Manufacturer Contact
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key10770330
MDR Text Key230223840
Report Number3005094123-2020-00241
Device Sequence Number1
Product Code CDP
UDI-Device Identifier00380740014285
UDI-Public00380740014285
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/02/2021
Device Model Number7K63-25
Device Catalogue Number07K63-25
Device Lot Number14456UI00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received11/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction Number3005094123-10/22/18-001
Patient Sequence Number1
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