BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N.
FDA device recall Z-1561-2008 · posted 2008-08-08 · Terminated
Recall details
- Recalling firm
- BD Diagnostic Systems / Lee Laboratories
- Reason for recall
- Exhibits cross reactivity with Neisseria meningitides Group W135
- Action taken
- BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- GTJ
- Quantity affected
- 200 units
- Distribution
- Worldwide Distribution --- including USA and country of New Zealand.
- Date initiated
- 2007-09-06
- Date posted
- 2008-08-08
- Date terminated
- 2009-03-24
- Location
- Grayson, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (K844407) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-25 |