StatSensor/StatStrip 1.75 (REF 53401)Recalls & reported problems
Nova Biomedical Corporation · StatStrip StatSensor Docking Station · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00385480534017), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Smoking” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Smoking1
- Sparking1
- Thermal Decomposition of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2019Thermal Decomposition of Device; Smoking; Sparking; Thermal Decomposition of Device
ON (B)(6) 2019 NOVA WAS MADE AWARE OF AN ISSUE REGARDING NOVA STAT STRIP DOCKING STATION, SN (B)(4), SPARKING AND SMOKING.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9117805 ↗
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- VITROS 8150112Ortho-Clinical Diagnostics, Inc. · ACID, LACTIC, ENZYMATIC METHOD1 recall8 reports
- i-STAT 03P85-50Abbott Point Of Care Inc. · ACID, LACTIC, ENZYMATIC METHOD15 reports
- i-STAT 03P85-25Abbott Point Of Care Inc. · ACID, LACTIC, ENZYMATIC METHOD12 reports
- Atellica CH Lactate_2 (Lac_2) 11532568Siemens Healthcare Diagnostics Inc. · ACID, LACTIC, ENZYMATIC METHOD6 reports
- Lactate Gen.2 3183700190Roche Diagnostics GmbH · ACID, LACTIC, ENZYMATIC METHOD5 reports
- ARCHITECT 9P18-21Abbott Laboratories · ACID, LACTIC, ENZYMATIC METHOD4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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