Recall Z-0650-2014— Nova Biomedical Corporation
Class II · Terminated
Class II FDA medical device recall by Nova Biomedical Corporation, initiated 2013-10-10, terminated 2014-03-24. It names 3 FDA 510(k) clearances: K070068, K063821, K060345. Product: Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.. Reason: Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage.
- Recalling firm
- Nova Biomedical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-10
- Terminated
- 2014-03-24
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
- K063821 — NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
- K060345 — NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
Reason for recall
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Data sourced from openFDA. This site is unofficial and independent of the FDA.