Recall of BD CMVScan Card Test Kit

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.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

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