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Open, Classified

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

FDA Recall Z-1599-2023 · Posted 2023-05-17

Recalling FirmBeckman Coulter, Inc.
Recall StatusOpen, Classified
Product CodeKQO
Date Initiated2023-04-05
Product Quantity306 units

Reason for Recall

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.

Firm Action

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."

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021-07-02K093861IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLEIris International, Inc. · 2010-02-05K022774IQ 200 SYSTEMIntl. Remote Imaging Systems · 2002-10-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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