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U.S. Department of Health and Human Services

Class 2 Device Recall Medonic MSeries Hematology Analyzer

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  Class 2 Device Recall Medonic MSeries Hematology Analyzer see related information
Date Initiated by Firm January 02, 2020
Create Date February 05, 2020
Recall Status1 Terminated 3 on November 03, 2022
Recall Number Z-1001-2020
Recall Event ID 84614
510(K)Number K083420  
Product Classification Counter, differential cell - Product Code GKZ
Product Medonic M-Series Hematology Analyzer
M16S BD ABR US
Product code: 1400075;
OUS Product code 1400011
Code Information Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019
Recalling Firm/
Manufacturer		 Clinical Diagnostic Solutions, Inc.
1800 NW 65th Ave
Plantation FL 33313-4544
For Additional Information Contact Deborah A Herrera
954-529-0721
Manufacturer Reason
for Recall		 A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
FDA Determined
Cause 2		 Software design
Action Consignees notified via email and postal delivery with recall letter dated 01/02/2020. The letter identified affected product, stated reason for recall, and provided specific actions to follow. A Recall Acknowledgement Form was requested to be returned by email, postal delivery, or fax. Clinical Diagnostic Solutions Inc. is handling US consignees only. Boule Medical AB is handling OUS consignees.
Quantity in Commerce 261
Distribution Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = BOULE MEDICAL AB
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