Z-0914-2020Class II

iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB...

Name: Z-0914-2020 iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB...
Creator: Beckman Coulter Inc.
Published: 2019-10-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-10-28 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB... on 2019-10-28. FDA classified it as Class II and gives the reason as "Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0914-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-28
Posted: 2020-01-29
Terminated: 2026-04-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.
Product code: LKM Counter, Urine Particle
Reason for recall: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: An Urgent Medical Device Recall letter was sent during the week of 10/28/2019 to the affected customers via mail and e-mail. The notice stated the misidentification issue as follows: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics)." The following actions were provided to reduce the potential for this issue until a software update is available: - Follow good laboratory practice (GLP) and ensure that a unique identification system is in place. - Ensure that specimens are labeled with a unique Specimen ID and manual orders utilize a unique Specimen ID. - Do not reuse barcode number that identify different specimens. If barcode numbers must be reused, ensure results have been released from the LIS and the instrument Work List has been cleared. - Clear all manual Orders immediately after results are released, even if barcodes are used for subsequent runs (see iQ200 or iChemVELOCITY IFU, Chaper 7, Manual Orders).
Quantity in commerce: 6601 devices
Distribution: Worldwide distributions.
Product codes and lots: UDI: 10837461001317, 10837461001355, 10837461001256,10837461001300; All Part Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0914-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0913-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0914-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29

Product code LKM

K022774Class IIIq 200 SystemIntl. Remote Imaging Systems / cleared 2002-10-21

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)