Genzyme Diagnostics Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay
Brand
Genzyme Diagnostics
Lot Codes / Batch Numbers
Lots 081077, 081093, 081138, 071093, 071138.
Products Sold
Lots 081077, 081093, 081138, 071093, 071138.
Genzyme Diagnostics is recalling Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as f due to False Positive results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False Positive results.
Recommended Action
Per FDA guidance
Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MD, OH
Page updated: Jan 10, 2026