BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Spa
FDA device recall Z-0570-2013 · posted 2012-12-19 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
- Action taken
- The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials. If further assistance is needed regarding replacements please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 12,250 tests
- Distribution
- Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
- Date initiated
- 2012-11-06
- Date posted
- 2012-12-19
- Date terminated
- 2013-01-09
- 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-MINOCYCLINE (GP) 1-32 UG/ML (K070809) | Becton, Dickinson & CO | 2007-09-24 |