STATSTRIP 1.0 (REF 47488)Recalls & reported problems
Nova Biomedical Corporation · StatStrip LAC Meter with Battery and Quick Reference Guide · Class 1
- 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 00385480474887), received between Sep 29, 2021 and Sep 29, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Imprecise or Erratic Results” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Imprecise or Erratic Results1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2021Imprecise or Erratic Results; Imprecise or Erratic Results
ON AUGUST 30, 2021, NOVA BIOMEDICAL CANADA WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING IMPRECISE LACTATE RESULTS ON A FETAL PATIENT WHILE USING A STAT STRIP LACTATE METER, SERIAL NUMBER (B)(6), AND LACTATE TEST STRIPS, LOT 2620345249. THE USER QUESTIONED THE RESULTS DURING OBSTETRIC SURGERY AND FOUND MORE BIAS IN THE METER RESULTS COMPARED TO THOSE FROM A BLOOD GAS ANALYZER. IT WAS LATER COMMUNICATED A CESAREAN SECTION (C-SECTION) WAS PERFORMED BECAUSE OF THE UNCERTAINTY OF THE RESULTS FROM THE METER IN AN EFFORT TO MITIGATE POTENTIAL HARM TO FETUS OR THE MOTHER. THE USER STATED THE C-SECTION MAY HAVE BEEN UNNECESARY BUT PROCEEDED BASED OFF THE RESULTS FROM THE METER. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 12547983 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.