DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

FDA device recall Z-1598-2023 · posted 2023-05-17 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

Action taken

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

Status

Open, Classified

Product code

KQO

Quantity affected

355 units

Distribution

Worldwide Distribution

Date initiated

2023-04-05

Date posted

2023-05-17

Location

Miami, FL

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