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
|