Skip to content

REV 2 Flowcell Capsule Spare, Part Number: C04154 recallZ-0786-2024 · Beckman Coulter, Inc. · initiated Dec 19, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0786-2024
Status
Open, Classified
Initiated by the company
Dec 19, 2023
Posted by the FDA
Jan 25, 2024
Recalling firm
Beckman Coulter, Inc.
Quantity
16 units
Product code
LKM
FDA submissions
K022774
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,

Product description

REV 2 Flowcell Capsule Spare, Part Number: C04154

Code information (models, lots, serial numbers)

UDI/DI15099590689452, All lot numbers

Other devices under the same FDA submission

4 devices cleared under K022774 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93655).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page