Recall and Use Update for StatStrip Glucose Hospital Meter Gen 2.0
The US FDA issued a correction and recall notice regarding the StatStrip Glucose Hospital Meter System Gen 2.0 manufactured by Nova Biomedical. The issue involves a risk where scanning barcodes can cause prior information to remain on the screen, potentially leading to glucose results being assigned to the incorrect patient or quality control ID. Unrecognized errors can result in delayed or inappropriate clinical management, posing serious risks particularly to critically ill patients and infants.
Nova Biomedical has placed a shipment hold on new Gen 2.0 devices while developing a permanent software update slated for a phased rollout. In the interim, the manufacturer and the FDA recommend specific mitigation steps. These include verifying patient identification details on screen before and after testing, configuring automatic operator logoffs, ensuring patient ID validation settings are active within NovaNet for systems using ADT, and switching to alternative meters if available.
Key points
- Affects only the StatStrip Glucose Hospital Meter System Gen 2.0 model numbers 63685 and 66739.
- Glitch can cause prior patient or QC barcode information to remain on screen, leading to misassigned test records.
- A software update is expected to roll out in a phased manner to permanently resolve the issue.
- Users are advised to use alternative meters if available, or follow strict on-screen verification and configuration mitigations.
What it means for you
Clinicians and hospital staff using the affected StatStrip Gen 2.0 glucose meters must strictly follow the recommended verification procedures for patient IDs before and after every test to prevent medication errors from misassigned results. If alternative meters are accessible, facilities should switch to them until the manufacturer's software update is implemented. Healthcare personnel in Pakistan should check with local suppliers or the Drug Regulatory Authority of Pakistan (DRAP) to determine if these specific Gen 2.0 models are in local use and to obtain any localized guidance.
Hospital Glucose Meter Correction: Nova Biomedical Updates Use Instructions for StatStrip Glucose Hospital Meter Systems
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.