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iQ200 Series Urine Microscopy Analyzer- All part numbers recallZ-1945-2020 · Beckman Coulter Inc. · initiated Mar 30, 2020

Class II Terminated All recalls posted in May 2020

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

A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 03/25/2020 Beckman Coulter Inc. sent out Urgent Medical Device Alert identifying the problem, the circumstances in which it can occur, the actions that should be taken by the customer/user in order to prevent risks to patients or users, and the actions planned by Beckman Coulter to correct the problem. PRODUCTS: Products installed between July of 2012 and December of 2014 are in scope of this field corrective action and can be identified by the name of the Product (all part numbers) that were installed in the time frames noted. ACTION TO BE TAKEN BY CUSTOMER/USER: If flames and or smoke be detected within the computer the customers/users should; follow laboratorys safety guidelines, contact Beckman Coulter by phone: call 800-526-7694 in the United States and Canada or if outside the United States and Canada, contact Beckman Coulter hotline or the local Beckman Coulter representative, and Follow Standard Operating Procedures (SOP) for Instrument backup testing methodology. This information should be communicated to all laboratory staff and retained as part of lab quality system documentation. Customers are asked to complete the Notification Response Form either electronically or manually depending on the method the notice was received. ACTIONS PLANNED BY BECKMAN COULTER: A Beckman Coulter service provider will proactively schedule a service visit to inspect the PC6 computer and replace the affected cable, if necessary. Additional potentially affected customers will be notified of the issue via Updated Urgent Medical Device Recall letter that will be sent during the week of 10/26/2020 via mail and/or e-mail. Note: Customers that received the initial letter but have any of the additional potentially affected devices will be re-notified of the issue.

Recall details

Recall number
Z-1945-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 30, 2020
Posted by the FDA
May 9, 2020
Recalling firm
Beckman Coulter Inc.
Quantity
3576 units
Product code
KQO
FDA submissions
K022774
Distribution
US Distribution: Nationwide Foreign Distribution: Worldwide

Product description

iQ200 Series Urine Microscopy Analyzer- All part numbers

Code information (models, lots, serial numbers)

Catalog Numbers: 00-3322, 700-3325, 700-3326, 700-3345, 700-3347, 700-3370, 700-3375, 700-3300RFB, B48999, C10683, C10684., All part 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.

Sources and updates

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