| Class 2 Device Recall Beckman Coulter iQ200 System Series Urine Microscopy Analyzers | |
Date Initiated by Firm | December 19, 2023 |
Date Posted | January 25, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0785-2024 |
Recall Event ID |
93655 |
510(K)Number | K022774 |
Product Classification |
Counter, urine particle - Product Code LKM
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Product | iQ200 Series Urine Microscopy Analyzers, Part Numbers:
a) 700-3320,
b) 700-3370,
c) 700-3345,
d) 700-3347,
e) C10683,
f) 700-3375,
g) 700-3325,
h) C10684 |
Code Information |
a) 700-3320, UDI/DI 10837461001188;
b) 700-3370, UDI/DI 10837461001324;
c) 700-3345, UDI/DI 10837461001300;
d) 700-3347, UDI/DI 10837461001317;
e) C10683, UDI/DI 15099590697129
f) 700-3375, UDI/DI 10837461001355;
g) 700-3325, UDI/DI 10837461001256;
h) C10684, UDI/DI 15099590695484;
All serial numbers |
Recalling Firm/ Manufacturer |
Beckman Coulter, Inc. 11800 Sw 147th Ave Miami FL 33196-2500
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For Additional Information Contact | Jennifer Chau 916-857-6006 |
Manufacturer Reason for Recall | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results. |
FDA Determined Cause 2 | Other |
Action | Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/19/2023 via first class mail and email. The notice explained the issue, its impact on test results, and requested the following actions be taken:
- Continue to run a complete Quality Control (QC) rack [including Iris Cleanser, Iris Diluent, iQ Focus and iQ Controls] as directed per iQ200 Series Instructions for Use (IFU) (300-4320 CE or 300-4321 EE) and DxU 850m and 840m Iris IFU (C49320 AB)
- If the QC passes:
o Run patient samples as routine
- If the QC fails:
o Refer to the IFU, Chapter 10 Troubleshooting; iQ200 Series IFU or DxU 850m and 840m Iris IFU
o If the failure persists, contact your Beckman Coulter Representative
- If a "Sequential Flags" Alarm displays:
Refer to the IFU, Chapter 10; Alarm #25; iQ200 Series IFU or DxU 850 and 840m Iris IFU
o If the alarm persists, contact your Beckman Coulter Representative
Additional weekly action if using DxU 850m/840m Microscopy Analyzers:
Visually inspect the iQClear Rinse Waste Well jets weekly for rust
o If the iQClear shows rust on the rinse jets, contact your Beckman Coulter Representative
Consult with your laboratory management to determine whether a retrospective review of results is necessary.
For questions regarding this notice, please contact Customer Support Center or your local representative;
From our website: http://www.beckmancoulter.com
By phone: call 800-526-7694 in the United States and Canada.
o Outside the United States and Canada, contact your local Beckman Coulter
representative. |
Quantity in Commerce | 112 units |
Distribution | US and Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LKM
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