FDA flags removal of newer StatStrip hospital glucose meters over patient-record errors
By Staff Writer · Published 10/21/2026, 12:07:19 AM ET
The recall covers Gen 2.0 models 63685 and 66739; hospitals should remove them when alternatives exist and verify patient IDs until a software fix arrives.
The Food and Drug Administration said Tuesday that Nova Biomedical is removing certain StatStrip Glucose Hospital Meter Systems while the company develops a software update. The FDA classified the action as the most serious type of recall because a result can be attached to the wrong patient's record, creating a risk of inappropriate treatment or delayed care.
The recall covers the newer Gen 2.0 StatStrip Glucose Hospital Meter System, model 63685, and the Glucose Hospital Meter System Multipack, model 66739. Both use device identifier 00385480636858, and the issue applies across all firmware versions. The FDA said earlier StatStrip models, including Gen 1.86, are not covered.
Nova told customers that previously scanned patient or quality-control information can remain on the meter screen. If staff accept that information, the glucose reading may be filed under the wrong patient. The company said the problem does not change the analytical accuracy of the glucose measurement itself.
The FDA said an incorrect record could prompt unnecessary insulin, delay needed treatment or cause clinicians to miss treatment for the intended patient. As of October 5, the agency reported one serious injury and no deaths. Nova's revised advisory disclosed 71 customer reports and one U.S. adverse event but described no serious adverse events, a different characterization from the FDA's current recall page.
Nova placed new Gen 2.0 shipments on hold and said it intends to phase in a software update during November. Until a fix is available, facilities with an alternative device should stop using affected meters. Facilities without an alternative should enable patient-ID validation when available, require an automatic operator logoff after each test, verify the patient's identity both before accepting the scan and after the result appears, and promptly correct any result filed in the wrong medical record.
The company directs U.S. customers with questions to 800-545-6682. Health professionals and consumers can report adverse reactions or quality problems through the FDA's MedWatch program.
What it means
This is a hospital-device recall, not a general recall of home glucose meters. Patients and families should not assume that a personal meter is affected. Anyone concerned about a hospital glucose result should contact the treating clinical team rather than attempt to identify or update hospital equipment.
The planned November software rollout is the company's intended schedule, not a guarantee that every affected meter will be updated at once. The FDA's current instructions leave facilities responsible for removing affected meters when alternatives exist and using the specified safeguards when they do not.
Source
This State & Nation summary is based on U.S. Food and Drug Administration’s original release, dated 2026-10-20. The reporting and statistics above are attributed to that publication.