Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
FDA device recall Z-0247-2007 · posted 2006-12-05 · Terminated
Recall details
- Recalling firm
- Dade Behring, Inc.
- Reason for recall
- Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
- Action taken
- On 9/27/06, the firm initiated the recall and its notification was via phone calls and letters (FedEx''ed) explaining the reason for the recall and requesting the product be discarded.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIE
- Quantity affected
- 828 units
- Distribution
- Worldwide, including USA, China, and Germany.
- Date initiated
- 2006-09-27
- Date posted
- 2006-12-05
- Date terminated
- 2006-12-28
- Location
- West Sacramento, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROMPT INOCULATION SYSTEM (K820299) | 3M Company | 1982-03-15 |