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U.S. Department of Health and Human Services

Medical Devices

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MicroScan® Rapid Pos Inoculum Broth

Class 1 Recall
Date Recall
Initiated:
February 7, 2005
Product:
MicroScan® Rapid Pos Inoculum Broth, Catalog # B1015-14, Lot numbers 050905A-1, 051005A-1, 051605A-1, 051705A-1, 052305B-1, and 052805B-1. Three hundred twenty-four (324) boxes were distributed to forty (40) domestic consignees from 11/1/04 to 1/31/05.
Use:
MicroScan® Rapid Pos Inoculum Broth is used to inoculate MicroScan® Rapid Fluorogenic Gram Positive MIC/BP panels, which are intended for the determination of antimicrobial susceptibility of gram-positive organisms. The test results for the MicroScan® Rapid Fluorogenic Gram Positive MIC/BP panels are provided in 3.5 to 15 hours as opposed to greater than 16 hours for the MicroScan® Dried overnight Gram positive panels.
Recalling Firm:
Dade Behring Inc.
2040 Enterprise Blvd.
West Sacramento, CA 95691
Reason for Recall:
Dade Behring initiated a product recall to prevent health risk to patients due to potential false antibiotic susceptibility results. The possibility of inaccurate susceptibility results for a pathogen could lead a physician to prescribe incorrect or suboptimal therapy.
Public Contact:

Customers with questions may contact the Dade Behring MicroScan technical assistance center at 1-800-677-7226.

FDA District:

San Francisco

FDA Comment:

Dade Behring notified the 68 laboratories that received the recalled product on January 26, 2005. Each laboratory was notified both by an overnight letter and either received a personal visit or a telephone call from Dade Behring to clarify actions to be taken by the laboratory regarding the product recall.

Dade Behring recommended that laboratories use an alternative method for susceptibility testing of Gram positive bacterial isolation (e.g., MicroScan® Dried overnight Gram Positive panels), and review the susceptibility results obtained with the affected broth lots to determine if additional corrective actions should be taken in the affected institutions. Laboratories were instructed to contact physicians when appropriate.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

  For additional information on this product recall, see nearby links.