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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 23, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 15, 2004
Recall Number Z-0770-04
Recall Event ID 28473
510(K)Number k983399  
Product Classification Giardia Spp. - Product Code MHI
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
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 Contact Gene Goorchenko
858-777-2614
Manufacturer Reason
for Recall		 False Positive results.
FDA Determined
Cause 2		 Other
Action Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.
Quantity in Commerce 2671 kits
Distribution Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MHI and Original Applicant = GENZYME DIAGNOSTICS
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