- The FDA issued a Class I recall, the most serious kind of recall, for Baxter International Inc’s (NYSE:BAX) Dose IQ safety software used with Spectrum IQ Infusion System.
- The Dose IQ safety software allows care providers to create a drug library of pre-programmed dosing information for specific medications delivered into a person’s body in controlled amounts using the Spectrum IQ infusion pump.
- The recall occurred due to a software defect that may lead to mismatched drug information in drug libraries created using version 9.0.x of the computer-based software.
- If the software’s drug identifier does not match the drug information on the pump, it will lead to improper drug configuration and causing a delay in therapy, under-infusion, or over-infusion of medication.
- There have been 15 complaints, no injuries, and no deaths reported for the issue.
- In total, Baxter Healthcare recalled 61 devices since initiating the recall on July 7, 2021.
- Price Action: BAX shares closed lower by 0.16% at $73.86 on Thursday.
- Related content: Benzinga’s Full FDA Calendar.
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