BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
This recall has been terminated (originally issued December 19, 2012).
- Recall Initiated
- November 6, 2012
- Posted
- December 19, 2012
- Terminated
- January 9, 2013
- Recall Number
- Z-0570-2013
- Quantity
- 12,250 tests
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Distribution
Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
Lot / Code Info
Lot number 2053373
Root Cause
Nonconforming Material/Component
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.