Date Initiated by Firm |
March 02, 2018 |
Create Date |
April 11, 2018 |
Recall Status1 |
Terminated 3 on July 06, 2023 |
Recall Number |
Z-1362-2018 |
Recall Event ID |
79566 |
510(K)Number |
K022774
|
Product Classification |
Automated urinalysis system - Product Code KQO
|
Product |
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
|
Code Information |
All |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
|
For Additional Information Contact |
469-961-4941
|
Manufacturer Reason for Recall |
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.
|
FDA Determined Cause 2 |
Use error |
Action |
The customers were contacted initially by the Urgent Medical Device Recall letter on 03/028/2018 delivered by email and US Mail.
Beckman Coulter will schedule a sites visit to verify the reporting units of measurement for casts for the laboratory within 90 days of this recall initiation. The use of Casts/HPF is not a common setting worldwide. |
Quantity in Commerce |
5247 units |
Distribution |
Worldwide |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KQO and Original Applicant = INTL. REMOTE IMAGING SYSTEMS
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