Z-2184-2018Class II

CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96...

Name: Z-2184-2018 CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96...
Creator: Cellavision AB
Published: 2017-12-04
License: https://open.fda.gov/license/

Cellavision AB / initiated 2017-12-04 / Open, Classified / root cause: software

FDA source

Cellavision AB began a recall of CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are... on 2017-12-04. FDA classified it as Class II and gives the reason as "A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2184-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-12-04
Posted: 2018-06-13
Recalling firm: Cellavision AB
Product: CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Product code: JOY Device, Automated Cell-Locating
Reason for recall: A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
Root cause tag: software
FDA root cause: Software design
Action: CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017. The letter identified affected product, problem and the actions to be taken. Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch. Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to their local distributor. For technical questions contact CelleVision ([email protected])
Quantity in commerce: Instruments: 224 Software: 99 (US)
Distribution: US Nationwide in the states of FL, IL, NY, and NC
Product codes and lots: Versions 6.0.1 or 6.0.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2184-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2184-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-06-20	2018-06-13

Product code JOY

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)