Z-0516-2020Class II

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) -

Name: Z-0516-2020 UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) -
Creator: Beckman Coulter, Inc.
Published: 2019-10-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-10-07 / Terminated

FDA source

Beckman Coulter, Inc. began a recall of UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker... on 2019-10-07. FDA classified it as Class II and gives the reason as "When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0516-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Posted: 2019-11-22
Terminated: 2021-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Product code: GKZ Counter, Differential Cell
Reason for recall: When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.
FDA root cause: Under Investigation by firm
Action: Consignees were notified via email and mail with an Urgent Medical Device Recall letter, dated 10/02/2019. Four consignees were notified with a letter dated 10/18/2019. The letter identified affected product, stated the issue, provided action to be taken to determine if consignee is affected, and stated that a hardware change was in progress to eliminate the issue. A response form was asked to be returned. Questions can be directed to Beckman Coulter Customer Support Center at 800-526-7694.
Quantity in commerce: 1,056 (418 US, and 638 OUS)
Distribution: Worldwide distribution - US Nationwide distribution and countries of Australia, Bahrain, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Product codes and lots: Catalog Number 775222. 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0516-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0516-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code GKZ

K140911Class IIUnicel Dxh 800 Coulter Cellular Analysis System/ Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc. / cleared 2014-09-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)