Z-1596-2023Class II

iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite...

Name: Z-1596-2023 iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite...
Creator: Beckman Coulter, Inc.
Published: 2023-04-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-04-05 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of 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... on 2023-04-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1596-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-05
Posted: 2023-05-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: KQO Automated Urinalysis System
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 root cause: Under Investigation by 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."
Quantity in commerce: 1068 units
Distribution: Worldwide Distribution
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1596-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1596-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-17
Z-1597-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-17
Z-1598-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-17
Z-1599-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-17

Product code KQO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)