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Notice to Readers: Update: Manufacturer's Recall of Rapid Cartridge
Assay Kits on the Basis of False-Positive
Cryptosporidium Antigen Tests
On March 23, this notice was posted as an MMWR Dispatch on the MMWR website (http://www.cdc.gov/mmwr).
On March 4, 2004, CDC announced that a manufacturer had voluntarily recalled rapid cartridge assay kits because of false-positive Cryptosporidium antigen tests
(1). An additional lot of a
Cryptosporidium/Giardia rapid assay has been
recalled voluntarily from laboratories by the distributor (Meridian Bioscience, Inc., Cincinnati, Ohio) on the basis of their
findings that Cryptosporidium-negative samples were weakly reactive with this lot (ImmunoCard
STAT!®, lot no. 081138 [expires October 5, 2004]). CDC recommends reconfirmation of positive test results (by using direct fluorescent antibody testing or modified acid-fast stained smears) obtained with ImmunoCard
STAT!® rapid assays from all recalled lots.
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Health and Human Services.References to non-CDC sites on the Internet are
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endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
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