Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for
FDA device recall Z-1783-2010 · posted 2010-06-10 · Terminated
Recall details
- Recalling firm
- Nova Biomedical Corporation
- Reason for recall
- Glucose strips report low glucose results
- Action taken
- Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 392 Cases (1800 strips each)
- Distribution
- Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.
- Date initiated
- 2010-02-12
- Date posted
- 2010-06-10
- Date terminated
- 2011-07-22
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM (K070960) | Nova Biomedical Corp. | 2007-07-11 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K063821) | Nova Biomedical Corp. | 2007-01-24 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (K060345) | Nova Biomedical Corp. | 2006-04-28 |