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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of BD CMVScan Card Test Kit-Becton Dickinson Diagnostics

DATE RECALL INITIATED:

June 20, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Catalog No. 255205 (500 tests/kit) / 6095886 / 8/31/2006
Catalog No. 255001 (100 tests/kit) / 6095884 / 8/31/2006
Catalog No. 255126 (30 tests/kit) / 6114596 / 10/31/2006

MANUFACTURER:

Becton Dickinson Diagnostics
Sparks, MD

REASON:

Becton Dickinson (BD) has determined that these lot numbers of CMVScan test kits may result in false positive results when testing with plasma specimens (EDTA, CPD, CP2D have been reported). BD is requesting customers to discontinue use of these lot numbers and discard any remaining packages. They further recommend the results of testing using plasma specimens be confirmed using another CMV testing method and if a false positive plasma result was reported, to contact the requesting physician.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448