Food, drugs, devices › Nova Biomedical Corporation
Device recall: Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Nova Biomedical Corporation (Waltham, MA) initiated this device recall on 25 Feb 2013; FDA lists 2 product records under event 64638, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 26 Sep 2014. Initiation: voluntary: firm initiated. Nova Biomedical Corporation has 7 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nova Biomedical Corporation, Waltham, MA.
Reason for recall
"Glucose test strips reports no result message when tested"
Distribution
"Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1153-2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | 7433 cases | Class II | Terminated | 1 May 2013 |
| Z-1154-2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only) | 2200 cases | Class II | Terminated | 1 May 2013 |
Context
Other enforcement events for Nova Biomedical Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jul 2026 | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. | Device | Class I | 5 |
| 20 Nov 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati | Device | Class I | 3 |
| 18 Sep 2023 | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, an | Device | Class II | 2 |
| 19 Jun 2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile P | Device | Class II | 1 |
| 10 Oct 2013 | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Cr | Device | Class II | 1 |
| 15 Jul 2013 | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are | Device | Class I | 10 |
All 7 events for Nova Biomedical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Glucose test strips reports no result message when tested"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.