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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TSH

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A.I.D.D LONGFORD ALINITY I TSH Back to Search Results
Catalog Number 07P48-30
Device Problems Unable to Obtain Readings (1516); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 10/24/2018
Event Type  malfunction  
Manufacturer Narrative
A product recall letter was issued to customers who received shipments of the affected alinity reagents to inform them of the manufacturing issue identified with the reagent cartridge bottle necks. The letter instructs the customer to manually inspect each reagent cartridge in inventory before use. Stat assays, alinity i stat high sensitive troponin- i and alinity i total b-hcg, should be inspected first as a priority to ensure no delay in testing for those assays. The following alinity i tsh lots are included in this correction: 90061ui00, 91526ui00 and 92291ui00. The fda division has been notified of this product recall. Removals and corrections report number: 3005094123-11/21/18-002-r note: additional products within the scope of this product recall that were distributed in the u. S. Have been filed under mdrs 3005094123-2018-00128, 3005094123-2018-00129, 3005094123-2018-00130, 3005094123-2018-00131, 3005094123-2018-00132 and 3005094123-2018-00133. Impacted products that were not distributed in the u. S. Have also been included in the scope of this field action documentation. Additional lot information: lot 91526ui00: manufacture date: 09/10/2018, expiration date: 08/27/2019. Lot 92291ui00: manufacture date: 10/12/2018, expiration date 09/24/2019.
 
Event Description
Abbott laboratories has become aware of a manufacturing issue that can result in damage to a bottle neck in some reagent cartridges. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the alinity i instrument. When the failure occurs, error codes will be generated which may lead to the potential of delayed patient results. No patient injury has been reported due to this issue.
 
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Brand NameALINITY I TSH
Type of DeviceTSH
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford NA
EI NA
Manufacturer (Section G)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford NA
EI NA
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key8096950
MDR Text Key128113527
Report Number3005094123-2018-00127
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/10/2019
Device Catalogue Number07P48-30
Device Lot Number90061UI00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number3005094123-11/21/18-002R

Patient Treatment Data
Date Received: 11/21/2018 Patient Sequence Number: 1
Treatment
ALINITY I SYSTEM CONTROL MODULE, LIST 03R65
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