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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 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.

Reference

  1. CDC. Manufacturer's recall of rapid cartridge assay kits on the basis of false-positive Cryptosporidium antigen tests---Colorado, 2004. MMWR 2004;53:198.

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.


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This page last reviewed 3/23/2004