Baxter Healthcare ABACUS TPN recall — FDA Z-1376-2022
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the…
Kits contain leaking bottles of isopropyl alcohol
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical…
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Kits contain leaking bottles of isopropyl alcohol
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Kits contain leaking bottles of isopropyl alcohol
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1.…
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical…
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
The product may be potentially positive for Salmonella due to one of the sub-ingredients (oregano) testing positive for Salmonella.
Listeria monocytogenes contamination.
Detectable levels of Per- and polyfluoroalkyl substances (PFAS).
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Presence of particulate matter: particulate identified as a beetle.
FAILED DISSOLUTION SPECIFICATIONS
Labeling: Missing label: Label missing from some prefilled pens.
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Browse recent months with enough recall history for useful comparison.