Date Initiated by Firm |
February 17, 2020 |
Create Date |
March 20, 2020 |
Recall Status1 |
Terminated 3 on May 13, 2021 |
Recall Number |
Z-1535-2020 |
Recall Event ID |
85047 |
510(K)Number |
K101852
|
Product Classification |
Automated urinalysis system - Product Code KQO
|
Product |
iChemVELOCITY Strips, Catalog 800-7212 |
Code Information |
Catalog 800-7212, UDI 10837461002628; Lot 7212269M |
Recalling Firm/ Manufacturer |
Beckman Coulter, Inc. 11800 SW 147th Ave Miami FL 33196-2500
|
For Additional Information Contact |
Roger Janczak 305-380-4189
|
Manufacturer Reason for Recall |
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC. |
Quantity in Commerce |
10822 vials |
Distribution |
Distribution in US including Puerto Rico, Canada, and Taiwan |
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 = KQO and Original Applicant = IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
|