Recall Z-1599-2023
Beckman Coulter, Inc. · initiated April 5, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Codes / lots: UDI/DI 15099590735982, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6
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.
FDA-determined cause: Under Investigation by firm
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."
Details
- Recall number
- Z-1599-2023
- Initiated
- April 5, 2023
- Posted by FDA
- May 17, 2023
- Product code
- KQO – Automated Urinalysis System
- Quantity
- 306 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Beckman Coulter, Inc., Miami, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1596-2023 Class II | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and…Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had… | 04/05/2023Open, Classified |
| Z-1597-2023 Class II | DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic…Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | 04/05/2023Open, Classified |
| Z-1598-2023 Class II | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic…Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | 04/05/2023Open, Classified |