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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 23, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 15, 2004
Recall NumberZ-0770-04
Recall Event ID 28473
510(K)NumberK983399 
Product Classification Giardia Spp. - Product Code MHI
ProductGiardia/ 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
Code Information Lots 081077, 081093, 081138, 071093, 071138.
Recalling Firm/
Manufacturer
Genzyme Diagnostics
6659 Top Gun St
San Diego CA 92121-4113
For Additional Information ContactGene Goorchenko
858-777-2614
Manufacturer Reason
for Recall
False Positive results.
FDA Determined
Cause 2
Other
ActionRecall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.
Quantity in Commerce2671 kits
DistributionProduct was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MHI
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