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BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged… recallZ-1847-2011 · Becton Dickinson & Co. · initiated Feb 28, 2011

Terminated All recalls posted in March 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Mixed-up of materials/components

What the company is doing

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.

Recall details

Recall number
Z-1847-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 28, 2011
Posted by the FDA
Mar 30, 2011
Recalling firm
Becton Dickinson & Co.
Quantity
377 cartons
Product code
LON
FDA submissions
K033458
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

Lot 0223498 exp 8/31/2011

Other devices under the same FDA submission

5 devices cleared under K033458 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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