OmniCell, Inc. Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Brand
OmniCell, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
Products Sold
UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
OmniCell, Inc. is recalling Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes due to IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, NY
Page updated: Jan 10, 2026