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Terminated

BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663*** The BD Phoenix Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type.

FDA Recall Z-1847-2011 · Posted 2011-03-30

Recall StatusTerminated
Product CodeLON
Date Initiated2011-02-28
Date Terminated2013-01-30
Product Quantity377 cartons

Reason for Recall

In vitro diagnostic test kit is defective and may cause false positive or false negative results.

Firm Action

BD Diagnostics Systems sent an Urgent Product Recall letter dated February 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinsue use of the affected product and discard any remaining packages. BD would issue replacements for the discarded material. Customers were instructed to complete the attached form whether or not they had any inventory remaining so that the firm may acknowledge receipt of this notification. Complete and fax the form to BD Regulatory Compliance to 410-316-4258. For further assistance contact BD Customer Service at 1-800-675-0908. For other inquiries, contact BD Technical Services at 1-800-638-8663.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution - USA including AZ, CA, FL, GA, MA, MD, NC, NY, PA, TX, WA, WI, and WY and the countries of The product was distributed to medical facilities nationwide and to foreign consignees in Argentina, Brazil, Chile, and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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