Z-2225-2012Class II

UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated...

Name: Z-2225-2012 UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated...
Creator: Beckman Coulter Inc.
Published: 2011-12-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-12-13 / Terminated

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that... on 2011-12-13. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2225-2012
Classification: Class II
Status: Terminated
Initiated: 2011-12-13
Posted: 2012-08-20
Terminated: 2012-08-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH Slidemaker Stainer Instrument System, PN 775222. 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. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.
Product code: CKG Radioimmunoassay, Acth
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers whic
FDA root cause: Process change control
Action: Beckman Coulter initiated a "PRODUCT CORRECTIVE ACTION (PCA)" which was communicated via phone calls starting the week of December 19, 2011 to all customers who purchased UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System. The phone calls provided the customers with an explanation of the problem identified, potential impact should the problem occur and an action to be taken. Customers were instructed to share the PCA information with their laboratory staff and if they had any questions, they should contact Beckman Coulter at (800) 526-7694.
Quantity in commerce: 41 units (15 units in the US)
Distribution: Worldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland.
Product codes and lots: Part Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029, AT40030, AT45031, AT45032, AT45033, AT45034, AT45035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2225-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2225-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20
Z-2226-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20

Product code CKG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)