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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT CREATINE KINASE CREATINE KINASE (CK)

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ABBOTT MANUFACTURING INC ARCHITECT CREATINE KINASE CREATINE KINASE (CK) Back to Search Results
Catalog Number 07D63-21
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A product recall letter was issued to all architect customers who have received architect creatine kinase, list number 07d63-21, lot number 24358un18. The letter informs the customer of the issue regarding a stability issue that may lead to quality control results shifting low out of range and/or error code 1054 "unable to calculate result, reaction check failure" for quality control and patient samples. The letter instructs the customer to discontinue use of the suspect lots and destroy any remaining inventory. The cause of the stability failure has been traced to a contamination of the bulk material.
 
Event Description
The customer observed error code 1054 unable to calculate result, reaction check failure, for controls when using the architect creatine kinase assay (list number 7d63, lot number 24358un18). There was no report of incorrect patient results or impact to patient management.
 
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Brand NameARCHITECT CREATINE KINASE
Type of DeviceCREATINE KINASE (CK)
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key8196429
MDR Text Key131926221
Report Number1628664-2018-02187
Device Sequence Number1
Product Code CGS
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K983070
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 Recall
Type of Report Initial
Report Date 12/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/05/2018
Device Catalogue Number07D63-21
Device Lot Number24358UN18
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 Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number1628664-07/19/18-002-R

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