CLASS II Device recall · Reported 1 May 2013 · FDA Enforcement Report
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) recalled
Nova Biomedical is recalling Nova StatStrip Xpress Glu-Test Strips (Glucose test strips), distributed nationwide in the US. The recall was initiated on 25 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1154-2013
- FDA event ID
- 64638
- Recalling firm
- Nova Biomedical, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2013
- FDA classified
- 19 Apr 2013
- Reported
- 1 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 25 Feb 2013 | Recall initiated by company | |
| 19 Apr 2013 | Classified by FDA | +53 days |
| 1 May 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Glucose test strips reports no result message when tested
Product as listed by the FDA
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
Where it was distributed
Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
Questions about this recall
Why was it recalled?
Glucose test strips reports no result message when tested
Which lots are affected?
Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015
Where was it sold?
Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 64638This product is part of a recall event; the main page for the event is Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) recalled | Nova Biomedical | Other | Nationwide |
More recalls from Nova Biomedical
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 465| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |