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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

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ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD ANALYZER; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
Catalog Number 09H39-01
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A product recall letter has been issued to all customers who have installed instruments with the impacted serial numbers and customers who have received the impacted emerald diluent tubing.The letter informs the customer of the following: - abbott representative will be contacting them to schedule an appointment to replace the tubing.The customer may continue to operate their instrument per the requirements outlined in section 5 of the operators manual, background counts must be within acceptable limits before running controls or patient specimens and all data should be considered for patient care management.If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
 
Event Description
The customer was notified of the product recall for the cell-dyn emerald diluent tubing on an impacted cell-dyn emerald analyzer and subsequently requesting for replacement of the tubing.There was no patient involvement and no impact to patient management was reported.
 
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Brand Name
CELL-DYN EMERALD ANALYZER
Type of Device
AUTOMATED HEMATOLOGY ANALYZER
Manufacturer (Section D)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
Manufacturer (Section G)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key8704763
MDR Text Key151148097
Report Number2919069-2019-00070
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740020088
UDI-Public00380740020088
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 06/17/2019
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 Catalogue Number09H39-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/13/2019
Initial Date FDA Received06/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction Number2919069-05/09/19-002-R
Patient Sequence Number1
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