Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials.
FDA device recall Z-0744-2007 · posted 2007-04-14 · Terminated
Recall details
- Recalling firm
- Mega Diagnostics
- Reason for recall
- Potential for microorganism growth in the alcohol standard.
- Action taken
- The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 6 units
- Distribution
- Country of Indonesia
- Date initiated
- 2006-09-20
- Date posted
- 2007-04-14
- Date terminated
- 2012-06-04
- Location
- Los Angeles, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ETHYL ALCOHOL STANDARD (K882117) | Verichem Laboratories, Inc. | 1988-08-04 |