Z-1617-2023Class II

Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model...

Name: Z-1617-2023 Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model...
Creator: OmniCell, Inc.
Published: 2023-03-27
License: https://open.fda.gov/license/

Omnicell, Inc. / initiated 2023-03-27 / Open, Classified / root cause: labeling and UDI

FDA source

OmniCell, Inc. began a recall of Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373 on 2023-03-27. FDA classified it as Class II and gives the reason as "IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1617-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-27
Posted: 2023-05-22
Recalling firm: Omnicell, Inc.
Product: Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Omincell notified Customers via phone on 3/27/2023 and by Urgent Field Action: Mandatory Correction Of Product Labeling Ivx Station (Limited Release) Letter on 3/31/2023 via email. Letter states reason for recall, health risk and action to take: We will analyze specific devices at your Limited Release sites. Upon completion of our analysis updated labeling will be provided and will include the revised dose accuracy range.
Quantity in commerce: 6 units
Distribution: AL, NY
Product codes and lots: UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1617-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1617-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-22

Product code NEP

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)