Recalls - April 27, 2004

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Class II

Genzyme Diagnostics voluntarily recalled 2,671 kits with five different lots of Giardia/Cryptosporidium Rapid In-vitro diagnostic Test Kits sold under two names: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay and Becton Dickenson (BD) ColorPac Giardia/Cryptosporidium Rapid Assay.
(April 27, 2004)

Meridian Bioscience, Inc., has voluntarily recalled three lots (lot no. 081077, expires July 11, 2004, lot no. 081093, expires August 11, 2004, and lot no. 081138, expires October 5, 2004) from laboratories due to false positive results. CDC recommends reconfirmation of positive test results obtained with ImmunoCard STAT!® rapid assays from these lots.

CDC Dispatch for lot no. 081093 and lot no. 081077
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm53d304a1.htm

CDC Dispatch for lot no. 081138
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm53d323a1.htm.

Becton Dickenson Also voluntarily recalled lot no. 071093 of the ColorPAC® Giardia/Cryptosporidium Rapid Assay test kit due to increased false positive results. Lot no. 071138 was not recalled by BD because it was still in BD’s possession (not yet distributed to customers) when recall by Genzyme Diagnostics took place. See recall letter by BD

Recall Letter by Becton Dickenson Text Word