FDA updated its Nova Biomedical recall notice on October 30 with the steps hospitals should take while the software fix is still pending. The Gen 2.0 StatStrip Glucose Hospital Meter can hold a previous patient's information on screen while an operator scans a patient ID or QC barcode. If the operator accepts it, the glucose result lands on the wrong record.
Affected products are model 63685 and the model 66739 multipack, across all firmware versions. Nova reported one serious injury as of October 5 and no deaths. Analytical performance is not in question. Only the identity attached to the number is.
The interim instructions: sites running ADT integration should enable Validate Patient ID's in NovaNet, set Operator Logoff Mode to Test so the operator logs out after each test, and verify the patient ID at the scan and again on the result screen. Nova has held shipment of new Gen 2.0 meters and plans a phased software rollout in November. Sites with an alternative meter should use it until theirs is updated.
Three of those four mitigations are bedside workflow changes, not settings a manufacturer can push remotely. That gap is what a human factors review is meant to close before clearance, not after a serious injury report.