Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
FDA device recall Z-0725-2008 · posted 2008-02-16 · Terminated
Recall details
- Recalling firm
- Nova Biomedical Corporation
- Reason for recall
- Incorrect Results - Creatinine results were lower than the laboratory reference method.
- Action taken
- Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CGL
- Quantity affected
- 300 units
- Distribution
- Nationwide Distribution, including the state of NY
- Date initiated
- 2007-11-02
- Date posted
- 2008-02-16
- Date terminated
- 2008-12-09
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS (K070068) | Nova Biomedical Corp. | 2007-05-07 |