EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro di
FDA device recall Z-0952-2009 · posted 2009-02-06 · Terminated
Recall details
- Recalling firm
- Epocal
- Reason for recall
- elevated range of potassium levels
- Action taken
- The recalling firm visited the hospital on 10/18/08 to conduct an investigation. At the end of the visit, the firm representatives removed the remaining cards from the hospital and returned to the manufacturing location.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 1000 test cards
- Distribution
- Nationwide Distribution --- including state of CA.
- Date initiated
- 2008-10-16
- Date posted
- 2009-02-06
- Date terminated
- 2009-02-06
- Location
- Ottawa, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPOC BLOOD ANALYSIS SYSTEM (K061597) | Epocal, Inc. | 2006-09-27 |