| | Class 2 Recall
BD Phoenix PMIC-108 Panels |  |
| Date Posted |
December 19, 2012 |
| Recall Number |
Z-0570-2013 |
| Product |
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. |
| Code Information |
Lot number 2053373
|
Recalling Firm/
Manufacturer |
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Ms. Gail Claiborne
410-316-4054
|
Reason for
Recall |
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
|
| Action |
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. |
| Quantity in Commerce |
12,250 tests |
| Distribution |
Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY. |
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