Recall Z-1599-2023— Beckman Coulter, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2023-04-05. It names 3 FDA 510(k) clearances: K210127, K093861, K022774. Product: UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis. Reason: 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..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-05
- Firm location
- Miami, FL, United States
510(k) clearances named in this recall
3 on FDA's record- K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- K093861 — IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
- K022774 — IQ 200 SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.