FDA Device recall Z-1596-2023
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345 by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1596-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-05 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
Product
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
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.
Identifiers
| code_info | a) iQ 200 Select, Part Numbers C10684, UDI/DI 15099590695484 and 700-3345, UD/DI 10837461001300; b) iQ 200 Elite, Part…a) iQ 200 Select, Part Numbers C10684, UDI/DI 15099590695484 and 700-3345, UD/DI 10837461001300; b) iQ 200 Elite, Part Numbers C10683, UDI/DI 15099590697129 and 700-3375, UDI/DI 10837461001355; c) iQ200 Select 1500, Part Number 700-3347, UD/DI 10837461001317; d) iQ200 Sprint, Part Number 700-3325, UDI/DI 10837461001256; All analyzers with Windows 10, Software Version 8.1; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1596-2023%22
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