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UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic… recallZ-1599-2023 · Beckman Coulter, Inc. · initiated Apr 5, 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 of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

FDA root cause category: Under Investigation by firm

What the company is doing

Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/05/2023 by mail. The notice explained the issue and the hazard and requested the following actions be taken: "Examine your specimen settings to determine if the optional 'Sperm Present' and 'Previous Sample Had Sperm' flags are enabled. If disabled, no further action is needed by your laboratory. If enabled, follow the actions below If the presence of sperm is identified: Review the previous specimen for the presence of sperm. Follow recommendations under Previous Sample Had Sperm in the iQ200 Series Instructions For Use (IFU) 300-4320CE and 300-4321EE and DxU 850m and DxU 840m Iris IFU (C49320AB) in Chapter 6, Data Review, Flags, Previous Sample Had Sperm, Recommendations. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter."

Recall details

Recall number
Z-1599-2023
Status
Open, Classified
Initiated by the company
Apr 5, 2023
Posted by the FDA
May 17, 2023
Recalling firm
Beckman Coulter, Inc.
Quantity
306 units
Product code
KQO
FDA submissions
K093861, K210127, K022774
Distribution
Worldwide Distribution

Product description

UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

Code information (models, lots, serial numbers)

UDI/DI 15099590735982, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K093861, K210127, K022774 are not named by identifier in this recall. 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 92056).

Sources and updates

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