BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Compa
FDA device recall Z-0366-2011 · posted 2010-11-15 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.
- Action taken
- BD Diagnostic Systems issued an "Urgent Product Recall" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded. For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 1675 units
- Distribution
- Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.
- Date initiated
- 2010-05-14
- Date posted
- 2010-11-15
- Date terminated
- 2010-11-29
- Location
- Sparks, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML (K021954) | Becton, Dickinson & CO | 2002-08-01 |